Home NDC 81522-095 Acetaminophen PM
Product NDC 81522-095
11-digit product format 815220095
Labeler code 81522
Product ID 81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler FSA STORE INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-02
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81522-095-03 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 3 81522-095-03 Acetaminophen PM 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-095 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.] 3 Current NDC, 2 package rows 20241018_f4322f34-ac19-371e-e053-2a95a90ac864.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81522-095-03 81522009503 1 BOTTLE, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-05-02 No No Current