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 71 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dye Free Infants Pain and Fever ACETAMINOPHEN WALGREENS 0b1d88d8-56ff-9e9d-e063-6394a90a015c 2024-04-09 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE H E B 4d572228-3141-4539-9c3d-2fd06e94eee3 2024-04-09 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 1b5ff867-5442-4cf8-bd1e-530093cc88f8 2024-04-05 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 0faa3592-4d56-4645-9a0e-066e0bdfebb6 2024-04-05 Warnings Exact identifier application number: M013 Pain Relief Childrens Dye Free ACETAMINOPHEN H E B 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 2024-04-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN H E B edb321dd-e5cb-4031-a8a8-efce9e86fe16 2024-04-03 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN H E B a0c0277e-50aa-4328-8f93-ab20c6176b2b 2024-04-03 Warnings Exact identifier application number: M013 Regular Strength Enteric coated aspirin ASPIRIN Bryant Ranch Prepack bda805ab-7f37-405d-a144-4e06ad9a29a1 2024-04-03 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Family Dollar (FAMILY WELLNESS) 650cb15e-c448-4df3-b0f8-4398be05d841 2024-03-27 Warnings Exact identifier application number: M013 Good Sense Effervescent Pain Relief ASPIRIN Perrigo Direct, Inc. 103027a7-2f0e-8d8c-e063-6294a90aedc7 2024-03-26 Warnings Exact identifier application number: M013 rugby infants acetaminophen ACETAMINOPHEN Rugby Laboratories 8aa9ac68-ca61-4163-a876-52034138c1ea 2024-03-25 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 08a18481-f029-f01f-e063-6294a90aac65 2024-03-21 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 0d106fa2-2a77-deb2-e063-6394a90a2dac 2024-03-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 872c5220-a379-4dc1-b99c-f11ebb82db35 2024-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 79886972-47a4-44c5-a131-1a691a328103 2024-03-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 5ffcc78d-9163-4cb4-8811-ae9f0142806a 2024-03-18 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER HF Acquisition Co LLC, DBA HealthFirst 13e621dc-b2b4-98fd-e063-6394a90acc75 2024-03-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS PHARMACY, INC 097a9c98-a092-400d-9600-6797b0b9a50c 2024-03-15 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets and Excedrin Tension Headache ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC 978a9d27-6d41-42cb-a193-11314923d2ac 2024-03-14 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC b3812d27-40af-40d7-864a-dfa4ae34cb9e 2024-03-14 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