Structured Product Labeling Validation Procedures

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This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation of the “Final Over-the-Counter (OTC) Drugs Monograph”, “Final All Over-the-Counter (OTC) Drugs Monograph”, “Not Final Over-the-Counter (OTC) Drugs Monograph” and “Combination Product Type Category under the NCI Code C102833”.


The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (drug monographs) for an OTC therapeutic drug class.

The first phase was accomplished by advisory review panels. The panels were charged with reviewing the active ingredients in OTC drug products to determine whether these ingredients could be generally recognized as safe and effective for use in self-treatment. They were also charged with reviewing claims and recommending appropriate labeling, including therapeutic indications, dosage instructions, and warnings about side effects and preventing misuse.

The agency published the panel’s conclusions in the Federal Register in the form of an advanced notice of proposed rulemaking (ANPR). After publication of the ANPR, a period of time was allotted for interested parties to submit comments or data in response to the proposal.

According to the terms of the review, the panels classified ingredients in three categories as follows:

Category I: generally recognized as safe and effective for the claimed therapeutic indication;
Category II: not generally recognized as safe and effective or unacceptable indications;
Category III: insufficient data available to permit final classification

The second phase of the OTC Drug Review is the agency’s review of active ingredients in each class of drugs, based on the panel’s review of ingredients, on public comment, and on new data that may have become available. The agency, in turn, publishes its conclusions in the Federal Register in the form of a tentative final monograph (TFM). After publication of the TFM, a period of time is allotted for interested parties to submit comments or data in response to the agency’s proposal.
The publication of final regulations in the form of drug monographs is the third and last phase of the review process. The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective. Products containing active ingredients or indications that are nonmonograph require an approved New Drug Application for marketing.

After publication, a final monograph may be amended, either on the Commissioner’s own initiative or upon the petition of any interested person. OTC drug monographs are continually updated to add, change, or remove ingredients, labeling, or other pertinent information, as needed.

Combination products are defined in the Code of Federal Regulations Title 21 (21 CFR 3.2(e)) as follows:

– A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity

– Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

– A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

– Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.” (1)

– Validation Procedures for Combination Product Type are as follows:
– Value code system is 2.16.840.1.113883.
– Value comes from the Combination Product Type list.
– Display name matches the value code
– If the document type is for bulk ingredient (53409-9), OTC animal drug (50577-6), OTC type A (50576-8), OTC type B (50574-3), OTC type C (50573-5), prescription animal drug (50578-4), VFD type A (50575-0), VFD type B (50572-7), VFD type C (50571-9), Cosmetic (58474-8), Dietary Supplement (58476-3), Medical food (58475-5), Human compounded drug (75031-5), Licensed Vaccine Bulk Intermediate (53406-5), Drug for Further Processing (78744-0) or Animal Compounded Drug Label (77647-6) then there is no combination product type characteristic on any package.

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United States


John Snow Labs; U.S. Food & Drug Administration;

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Source Citation



Final All Over-the-Counter Drugs, Final Over-the-Counter Drugs, Not Final Over-the-Counter Drugs, Structured Product Label, Drug Label, Drug Monograph List, OTC Drugs, Over The Counter Drugs, Over The Counter Medicine, Non-Prescription Drugs

Other Titles

OTC Monograph All Final List Validation, OTC Monograph Final List Validation, OTC Monograph Not Final List Validation

Validation_ProcedureType of the validation procedure i.e., Final OTC, Not Final OTC or Final All OTC or Combination Productstringrequired : 1
UNIIUNII (Unique Ingredient Identifier) of the active ingredient of OTC (over-the-counter) product or NCI (National Cancer Institute) code pertaining to the terms used in Combination Product Category Types.stringrequired : 1
CFR_CitationCitation in the Code of Federal Regulations (CFR)stringrequired : 1
Active_IngredientName of the OTC product's active ingredientstring-
Preferred_TermPreferred substance/combination product namestringrequired : 1
Not Final OTC63POE2M46Ypart356ELM
Not Final OTC7SEV7J4R1Upart347TALC
Not Final OTCJC71GJ1F3Lpart356MYRRH
Not Final OTC9679TC07X4part356IODINE
Not Final OTC89NA02M4RXpart356PECTIN
Not Final OTC9679TC07X4part333AIODINE
Not Final OTC9679TC07X4part333EIODINE
Not Final OTCR16CO5Y76Epart343ASPIRIN
Not Final OTC8T66I31YNKpart347ALDIOXA
Not Final OTCL7T10EIP3Apart348MENTHOL