Structured Product Labeling

$716 / year

The Structured Product Labeling dataset contains the most recent drug labeling information submitted to the Food and Drug Administration (FDA) and currently in use.
All labels information are published by DailyMed the official provider of FDA label information.

Complexity

The Structured Product Labeling dataset includes current drug labeling information like Product Name, Ingredients, Route of Administration, Package description and Indications approved by FDA for marketed products.
The regulations require that the content of labeling be submitted in a form that FDA can process, review, and archive.
Since 1999, FDA has been receiving the electronic content of labeling in Portable Document Format (PDF), and this format has allowed FDA to process, review
and archive the content of labeling.
FDA, working with other parties in HL7 (experts from HL7, industry, and technology solution providers), has adapted CDA for labeling in an HL7 standard called Structured Product Labeling (SPL). When compared with PDF, SPL exhibits the following advantages.
– SPL allows the exchange of information between computer systems in a way that cannot be accomplished with PDF. For example, the information in SPL can be used to support health information technology initiatives for improving patient care.
– The exchange of labeling changes with SPL can be easier and more efficient for both FDA and manufacturers when compared with PDF. For example, with SPL, only those sections or data elements of the labeling that are changed would need to be checked rather than the entire labeling.
– SPL allows automation of comparison of text by section and comparison of specific drug information data elements.
– SPL can also be used to exchange information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.

Date Created

2006-01

Last Modified

2019-06-19

Version

2019-06

Update Frequency

Monthly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; DailyMed, National Library of Medicine (NLM);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Structured Product Labeling, FDA Drug Labeling Information, Product Labeling, SPL, DailyMed

Other Titles

DailyMed Drugs Labeling, FDA Approved Drugs Labeling

NameDescriptionTypeConstraints
Product_NameThe Name of the productstring-
Product_TypeProduct type (Human/Animal, OTC/Prescription...)string-
IngredientsList of the ingredients of the productstring-
Route_Of_AdministrationRoute of Administration of the productstring-
Appearance_ShapeShape of the product (unit)string-
Appearance_SizeSize of the product (unit)string-
Appearance_ScoreProduct Characteristics: scorestring-
Package_DescriptionPackage Description of the productstring-
Dosage_FormDosage Form of the Productstring-
IndicationsIndications and Usage of the productstring-
ContraindicationsContraindications of the productstring-
Controlled_Substance_CodeControlled Substance Code in the product if includedstring-
Product NameProduct TypeIngredientsRoute Of AdministrationAppearance ShapeAppearance SizeAppearance ScorePackage DescriptionDosage FormIndicationsContraindicationsControlled Substance Code
Influenza A (H1N1) 2009 Monovalent VaccineVACCINEINFLUENZAAVIRUSA/CALIFORNIA/7/2009(H1N1)-LIKEHEMAGGLUTININANTIGEN(PROPIOLACTONEINACTIVATED)15ugINTRAMUSCULAR0.5 mL in 1 SYRINGE, GLASS;5 mL in 1 VIAL, MULTI-DOSE;10 in 1 CARTON;1 in 1 CARTONInfluenza A (H1N1) 2009 Monovalent Vaccine is supplied as a 0.5-mL prefilled single dose syringe, package of 10 syringes per carton. NDC 66521-200-02 Influenza A (H1N1) 2009 Monovalent Vaccine is supplied as a 5-mL multidose vial, individually packaged in a carton. NDC 66521-200-10 Store Influenza A (H1N1) 2009 Monovalent Vaccine refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light. Do not use after the expiration date. Between uses, return the multidose vial to the recommended storage conditions.Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see DESCRIPTION (11)].
INFLUENZA A (H1N1) 2009 MONOVALENT VACCINEVACCINEINFLUENZAAVIRUSA/CALIFORNIA/7/2009(H1N1)-LIKEANTIGEN(FORMALDEHYDEINACTIVATED)15ug,GELATININTRAMUSCULAR5 mL in 1 VIAL, MULTI-DOSE;1 in 1 CARTONSingle-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25. Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70. Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50. Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90. Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15. Vial stoppers and syringe plungers do not contain latex. Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Between uses, return the multi-dose vial to the recommended storage conditions at 2º to 8ºC (35º to 46ºF). Do not use after the expiration date shown on the label. Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25. Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70. Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50. Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90. Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15. Vial stoppers and syringe plungers do not contain latex.Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions (5) and Description (11) ]
INFLUENZA A (H1N1) 2009 MONOVALENT VACCINEVACCINEINFLUENZAAVIRUSA/CALIFORNIA/7/2009(H1N1)-LIKEANTIGEN(FORMALDEHYDEINACTIVATED)15ug,GELATININTRAMUSCULAR0.5 mL in 1 VIAL, SINGLE-DOSE;0.5 mL in 1 SYRINGE, GLASS;0.25 mL in 1 SYRINGE, GLASS;0.25 mL in 1 SYRINGE, GLASS;0.5 mL in 1 SYRINGE, GLASS;10 in 1 CARTON;10 in 1 CARTON;10 in 1 CARTON;25 in 1 CARTON;25 in 1 CARTONSingle-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25. Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70. Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50. Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90. Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15. Vial stoppers and syringe plungers do not contain latex. Store all Influenza A (H1N1) 2009 Monovalent Vaccine presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen. Between uses, return the multi-dose vial to the recommended storage conditions at 2º to 8ºC (35º to 46ºF). Do not use after the expiration date shown on the label. Single-dose prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-25. Single-dose prefilled syringe, without needle, 0.25 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-70. Single-dose prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton – Product No. NDC 49281-650-50. Single-dose prefilled syringe, without needle, 0.5 mL, package of 25 prefilled syringes per carton – Product No. NDC 49281-650-90. Single-dose vial, 0.5 mL, package of 10 vials per carton – Product No. NDC 49281-650-10. Multi-dose vial, 5 mL, one vial per carton. The vial contains ten 0.5 mL doses – Product No. NDC 49281-640-15. Vial stoppers and syringe plungers do not contain latex.Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions (5) and Description (11) ]
Tetanus and Diphtheria Toxoids AdsorbedVACCINECLOSTRIDIUMTETANI2.01,CORYNEBACTERIUMDIPHTHERIAE2.01,ALUMINUMPHOSPHATE,FormaldehydeINTRAMUSCULAR0.5 mL in 1 VIAL, SINGLE-DOSEThe stopper of the vial is latex free.MassBiologics' Td is supplied in single-dose (0.5 ml) vials.NDC No. 14362-0111-3 - Package of 10 single dose vials.MassBiologics' Td is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics' Td vaccine. (See DESCRIPTION). Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
Clease and TreatNON-STANDARDIZED ALLERGENICBENZOYLPEROXIDE0.8g,SELENIUMSULFIDE0.5g,AMMONIUMLAURYLSULFATE,CARBOMER934,GLYCERIN,METHYLPARABEN,PROPYLENEGLYCOL,PROPYLPARABEN,WATER,SODIUMCHLORIDE,SODIUMHYDROXIDE,AMMONIUMLAURYLSULFATE,POWDEREDCELLULOSE,GLYCERYLRICINOLEATE,TRISODIUMCITRATEDIHYDRATETOPICAL5 g in 1 POUCHEach Cleanse & Treat packette consists of one 0.8 g. 5% benzoyl peroxide pad and one 0.5 g. 2% salicylic acid pad, with each pad separated from one another by filmstock and both pads enclosed together in an individual heat-sealed foil pack bearing the NDC Number 23710-052-02. Store at 15°-25° C (59°-77° F)Cleanse & Treat is indicated for the topical treatment of acne vulgaris.Cleanse & Treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.
Weatherproof First Aid KitMEDICAL DEVICETOPICAL,TOPICAL,TOPICAL1 in 1 PACKAGE, COMBINATIONWeatherproof First Aid Kit 50 Person / Contains over 172 pieces CLEANSE Antiseptics 25 Antiseptic Towelettes TREAT Injury Treatment 1 Instant cold pack1 Triangular Bandage Ointments 10 Burn cream packets6 Triple Antibiotic Ointment PROTECT Adhesive Bandages 100 Adhesive plastic bandages, 3/4” x 3”16 Adhesive plastic bandages, 1" x 3" Non-Adhesive Bandages 1 Eye Pad 1 - 5/8" x 2 - 5/8"4 Gauze pads 2" x 2"6 Gauze pads 3" x 3'1 Elastic bandage Dressings 1 Absorbent pad 5" x 9" Tape 1 First aid tape roll, 1/2” x 5 yds Gloves 2 Medical grade gloves Other 1 First aid handbook1 Registration card Implements 1 Scissors1 Tweezers, plastic
Office First Aid KitMEDICAL DEVICETOPICAL,TOPICAL,TOPICAL1 in 1 PACKAGE, COMBINATIONOffice First Aid Kit 25 Person / Contains over 131 pieces CLEANSE Antiseptics 50 Alcohol Pads TREAT Injury Treatment 1 Instant cold pack Ointments 2 Antibiotic packets2 Burn cream packets PROTECT Adhesive Bandages 50 Adhesive plastic bandages, 3/4” x 3” Non-Adhesive Bandages 4 Gauze pads 2" x 2"6 Gauze pads 3" x 3'1 Elastic bandage Tape 1 First aid tape roll, 1/2” x 5 yds Gloves 10 Medical grade gloves Other 1 First aid handbook1 Registration card Implements 1 Scissors1 Tweezers, plastic
Triage First Aid StationMEDICAL DEVICETOPICAL,TOPICAL1 in 1 PACKAGE, COMBINATIONPhysicians Care CUTS AND SCRAPES 2 2" x 2" Gauze Pads 15 3/4" x 3" Adhesive Bandages 10 3/8" x 1 1/4" Adhesive Bandages 2 Antiseptic Wipes Physicians Care®is a Registered Trademark ofACME UNITED Corporation 60 Round Tree Hill Road, Fairfield CT 06824 Designed in the USA | Made in China Physicians Care BUMPS Contains 2 Cold Packs Physicians Care®is a Registered Trademark ofACME UNITED Corporation 60 Round Tree Hill Road, Fairfield CT 06824 Designed in the USA | Made in China Physicians Care BURNS 5 Burn Ointment Packets 5 3" Cotton Tip Applicators 4 2" x 2" Gauze Pads 2 1/2" x 5yd Tape Physicians Care®is a Registered Trademark ofACME UNITED Corporation 60 Round Tree Hill Road, Fairfield CT 06824 Designed in the USA | Made in China
Ready Care KitMEDICAL DEVICETOPICAL,TOPICAL,TOPICAL,TOPICAL1 in 1 PACKAGE, COMBINATIONPhysicians Care CLEANSE Antiseptics 14 Antiseptic Wipes16 Alcohol Pads TREAT 6 Antibiotic Ointment Packets 6 Burn Ointment Packets10 3" Cotton Tip Applicator PROTECT 16 3/8” x 1 1/2” Bandages16 1” x 3” Bandages80 3/4” x 3” Bandages1 1/2" Tape1 Triangular Bandage4 3" x 3" Sterile Gauze Pads1 Abdominal Compress Other Medical Exam Latex Gloves (2 Pair)1 Tweezers1 Cold Pack1 First Aid Guide10 Finger Splints Acme United Corporation60 Round Hill RoadFairfield CT 06824 www.acmeunited.com Designed in the USA | Made in China CAUTION: This product may contain natural rubber latex which may cause allergic reactions.This kit contains products that have expiration dates. Please check before use.
Ready Care XL KitMEDICAL DEVICETOPICAL,TOPICAL,TOPICAL,TOPICAL,ORAL,ORAL,ORALROUND,ROUND,ROUND10 mm,10 mm,12 mm1,1,11 in 1 PACKAGE, COMBINATIONPhysicians Care CLEANSE 20 Antiseptic Wipes20 Alcohol Pads TREAT 6 Antibiotic Ointment Packets 6 Burn Ointment Packets10 3" Cotton Tip Applicators PROTECT 3 Knuckle Bandages3 Fingertip Bandages35 3/8” x 1 1/2” Bandages16 1” x 3” Bandages200 3/4” x 3” Bandages1 1/2" Tape1 Triangular Bandage4 3" x 3" Sterile Gauze Pads1 Abdominal Compress Medicine 3 Acetaminophen Packets (packet of 2)3 Aspirin Packets (packets of 2)3 Antacid Packets (packets of 2) Other Gloves (2 Pair)1 Cold Pack1 First Aid Guide10 Finger Splints5 Disposable Thermometers1 Tweezer Acme United Corporation60 Round Hill RoadFairfield CT 06824 www.acmeunited.com Designed in the USA | Made in China CAUTION: This product may contain natural rubber latex which may cause allergic reactions.This kit contains products that have expiration dates. Please check before use.