Home NDC 85237-2945 Tylenol PM
Product NDC 85237-2945
11-digit product format 852372945
Labeler code 85237
Product ID 85237-2945_55d0dd09-882d-754a-e063-6294a90a15ee
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen and diphenhydramine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Select Consumer Group
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-11
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 2027-12-31
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 Tylenol PM
Brand name suffix Extra Strength
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup 1092378 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 19 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join M-PAP ACETAMINOPHEN Bryant Ranch Prepack c6cec390-004e-45f6-9388-c662a979f37d 2026-03-17 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Chain Drug Marketing Association, Inc. b32ada58-a098-47d2-9ed2-4d5918657709 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL H E B 21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Topco Associates, LLC eaa98783-5800-4ae9-832f-f4a1fd1790fd 2026-03-16 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Walgreen Company 413b3b95-2867-4534-8290-54f477cccf1e 2026-03-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Grocery Outlet, Inc. 4454d02a-ba49-6c8c-e063-6294a90a4709 2026-03-12 Warnings Exact identifier application number: M013 Aspirin Enteric Coated ASPIRIN CVS Pharmacy c55304be-bfc0-46a8-a37e-2e6ba9098394 2026-03-12 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Amerisource Bergen c280ac64-920c-4d03-9190-03e0196ed5ef 2026-03-11 Warnings Exact identifier application number: M013 Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 4cc4b39a-39d5-a2bb-e063-6394a90a2e95 2026-03-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED d79828d8-9279-4ae9-8872-aeca641be5d9 2026-03-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Preferred Pharmaceuticals Inc. 1b5b8bb1-c45d-48f0-b275-9ce1f769fed4 2026-03-09 Warnings Exact identifier application number: M013 foster and thrive childrens pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC e495a27e-eb64-4c42-8942-43bab9918172 2026-03-07 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL CVS PHARMACY 67a190c3-7de0-4f57-be94-d6b8285e1220 2026-03-06 Warnings Exact identifier application number: M013 Back and Body Pain Relief ASPIRIN, CAFFEINE WinCo Foods, LLC cf5c15e9-c45d-4bd6-a887-fd74de5f81b9 2026-03-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Topco Associates, LLC 87af092c-99e6-475d-81af-b9fd8fc337d7 2026-03-06 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN Rite Aid Corporation 879e2258-f61b-47ad-a4b1-7d1e78823570 2026-03-05 Warnings Exact identifier application number: M013 Aspirin ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE 87c580d3-6009-4be9-aea7-13539fbe6e31 2026-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable Orange ASPIRIN MAJOR PHARMACEUTICALS fb3a8e38-e991-49c9-93dc-1d29c0a97ba3 2026-03-05 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN Kroger 41e149df-4140-95cc-e063-6294a90a866b 2026-03-03 Warnings Exact identifier application number: M013 Medique Pain Off ACETAMINOPHEN, ASPIRIN, CAFFEINE Sportpharm LLC 2b35acdc-ff88-46e6-a108-5240aac1d53f 2026-03-03 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85237-2945-1 85237294501 1 POUCH in 1 BLISTER PACK (85237-2945-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 1 pouch 2022-06-01 No No Current 85237-2945-2 85237294502 2 POUCH in 1 BLISTER PACK (85237-2945-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 2 pouch 2022-06-01 No No Current 85237-2945-3 85237294503 20 POUCH in 1 CONTAINER (85237-2945-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 20 pouch 2022-06-01 No No Current 85237-2945-4 85237294504 25 POUCH in 1 CONTAINER (85237-2945-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 25 pouch 2022-06-01 No No Current 85237-2945-6 85237294506 50 POUCH in 1 CONTAINER (85237-2945-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 50 pouch 2022-06-01 No No Current 85237-2945-7 85237294507 3 POUCH in 1 BLISTER PACK (85237-2945-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 3 pouch 2022-06-01 No No Current