Store-brand OTC medicines

FDA's National Drug Code directory listed 56,901 human over-the-counter drug products as of Oct. 30, 2026. Close to two-thirds of them, 36,945, were marketed under an OTC monograph, with no product-specific FDA approval. Another 5,078 were marketed under abbreviated new drug applications, the same approval route prescription generics use, according to GxRadar's count of openFDA's NDC data¹.

Store-brand pain relievers, antihistamines and antacids sit in both groups. Which rules a given product follows depends mostly on its active ingredient and how that ingredient first reached pharmacy shelves without a prescription, a line between prescription and nonprescription drugs that dates to the Durham-Humphrey Amendment of 1951.

The distinction explains why two boxes with the same active ingredient and strength are regulated as the same active drug at the same strength, and it explains what the 2020 overhaul of the monograph system changed. Federal rules also require a Drug Facts label on every OTC product, which is where the comparison can be checked.

Two legal routes to the shelf

FDA created OTC drug monographs in 1972 as "a kind of 'recipe book' covering acceptable ingredients, doses, formulations, labeling, and testing," agency officials wrote in an FDA perspective piece on the program². A product that conforms to a monograph can be sold without FDA approving it first. One that does not conform needs an approved application.

Conforming means more than using an allowed ingredient. Under 21 CFR 330.1³, a monograph product must also be made under current good manufacturing practice, come from a registered establishment, be listed with FDA, and carry labeling in the required format. A product that "fails to conform to each of the conditions" is subject to regulatory action.

Ingredients that moved from prescription to OTC status through a new drug application take the other route. Copies of those products, store brands among them, reach the market through ANDAs and must show bioequivalence to a reference product, as prescription generics do (see how a generic drug gets approved and the 80-125 rule). FDA's Orange Book⁴ keeps a separate OTC Drug Product List for these approved products.

Source: GxRadar analysis of the openFDA NDC directory, data last updated Oct. 30, 2026. Counts are product listings; one product can be sold in several package sizes.

What the 2020 CARES Act changed

For decades, changing a monograph meant notice-and-comment rulemaking that "would often take years," the FDA perspective piece said. Section 3851 of the CARES Act⁵, signed March 27, 2020, added section 505G to the Federal Food, Drug, and Cosmetic Act and replaced that process with administrative orders.

FDA can now propose an order itself, and a manufacturer can request one through an OTC Monograph Order Request. Proposed orders get a public comment period before they are finalized. The law also created a user fee program, OMUFA, paid by monograph manufacturers. FDA said it had posted all 33 final orders that were "deemed established" when the law took effect, which set conditions for whole therapeutic categories, on its OTC Monographs@FDA⁶ portal.

Congress renewed the fee program in late 2025. A Federal Register notice from Dec. 29, 2025⁷ says the OTC Monograph Drug User Fee Amendments, or OMUFA II, enacted as part of Pub. L. 119-37, authorize fees for fiscal years 2026 through 2030.

The new process has already been used on a familiar ingredient. On Nov. 8, 2024, FDA issued a proposed order⁸ to remove oral phenylephrine from monograph M012, which covers cold, cough and allergy products, as a nasal decongestant ingredient "because they are not effective." The comment period closed May 7, 2025. Anyone with questions about a product containing it can ask a pharmacist.

How store brands compare under each route

For a monograph product, the monograph sets the active ingredient, the allowed strengths and doses, and much of the label text, and those conditions apply to every product sold under it whatever name is on the box. For an ANDA product, the store brand had to show FDA that it matches the reference product's active ingredient, strength, dosage form and bioequivalence.

What can differ is everything else. Inactive ingredients, such as dyes, flavors and coatings, vary among makers, which is also why tablets change color or shape between brands. Anyone with an allergy or sensitivity can compare the inactive ingredient lists and ask a pharmacist.

Which route a store brand takes tracks the ingredient's history. GxRadar's count of single-ingredient OTC listings in the openFDA NDC directory shows the split.

Source: GxRadar analysis of openFDA NDC data as of Oct. 30, 2026, matching the listed generic name exactly and ignoring capitalization. Zero means no listing under that exact name. A handful of listings may be coded inconsistently by their labelers.

Loratadine, cetirizine, famotidine and naproxen sodium were all prescription drugs first, so their store-brand versions are ANDA generics. Aspirin and diphenhydramine are monograph ingredients. Acetaminophen appears in both, since most products follow the monograph while some formulations came through applications.

Reading the Drug Facts label

Every OTC product must carry a Drug Facts panel in a fixed order, under 21 CFR 201.66⁹, a rule first published in the Federal Register on March 17, 1999. FDA's consumer page¹⁰ lists the sections (walked through in GxRadar's guide to reading a Drug Facts label): active ingredients with the amount in each dosage unit, purpose, uses, warnings, directions, other information and inactive ingredients.

To compare a store brand with a name brand, read the active ingredient line on both panels, including the salt form and the amount per tablet or per dose. FDA notes that the Drug Facts rules do not apply to dietary supplements, which carry a Supplement Facts panel instead, so a supplement on the same shelf is regulated as a food.

Labels are also searchable online. The National Library of Medicine's DailyMed¹¹ posts the label files that manufacturers submit, searchable by name or by the NDC number on the package. Recalls of OTC products, including the benzene recalls of sprays and sanitizers, appear in the same FDA enforcement data that feeds GxRadar's recall tracker.

OMUFA II runs through Sept. 30, 2030. A final order on oral phenylephrine, if FDA issues one, will be posted on OTC Monographs@FDA.