Home NDC 57344-095 Acetaminophen PM
Product NDC 57344-095
11-digit product format 573440095
Labeler code 57344
Product ID 57344-095_284d3315-9077-e45f-e063-6394a90af0c4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-10-01
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 57344-095-01 Acetaminophen PM 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 5 57344-095-01 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 5 57344-095-02 Acetaminophen PM 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 5 57344-095-02 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 5 57344-095-03 Acetaminophen PM 1 in 1 CARTON TABLET, COATED 1 5 57344-095-03 Acetaminophen PM 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5 57344-095-12 Acetaminophen PM 300 in 1 BOTTLE, PLASTIC TABLET, COATED 300 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57344-095 ACETAMINOPHEN PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 5 Current NDC, Legacy NDC, 7 package rows 20241204_409b5fcd-5880-4dda-85d8-26aeceb4f8ab.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 2 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MAX relief junior ACETAMINOPHEN Akron Pharma Inc. 0e43b885-3843-4f11-9a53-02a38c228313 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior CHILDREN ACETAMINOPHEN Akron Pharma Inc. d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior Grape CHILDREN ACETAMINOPHEN Akron Pharma Inc. 3c7a7f40-4963-4fd1-942e-93fa08a45830 2026-08-31 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 5a615118-33c9-1520-e063-6394a90a21a6 2026-08-31 Warnings Exact identifier application number: M013 acetaminophen extra strength ACETAMINOPHEN Sam's West Inc dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d 2026-08-28 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN HAWAII REPACK, INC. ac94cce3-9a39-41de-bb8b-10a5e5b8e83b 2026-08-28 Warnings Exact identifier application number: M013 Aspirin ASPIRIN WinCo Foods, LLC a0a19cd1-eb8a-4773-be00-78de90d2a3c3 2026-08-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN FSA STORE INC. 5502ef15-9f40-db56-e063-6394a90a2de4 2026-08-26 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d 2026-08-26 Warnings Exact identifier application number: M013 HyVee Extra Strength Headache Relief CAPLET ACETAMINOPHEN, ASPIRIN, CAFFEINE HyVee Inc 495c75bf-c09a-accd-e063-6294a90a75ec 2026-08-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walgreens 543f93d1-df14-0bd2-e063-6294a90a4413 2026-08-24 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Akron Pharma Inc. ab79fd60-8315-4c63-8045-1b0511ac268f 2026-08-24 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. 4fd048c3-70bc-2ea7-e063-6394a90a55f2 2026-08-22 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 59adabeb-97e8-2de4-e063-6394a90acc47 2026-08-22 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Publix Super Markets Inc a876daa7-ade3-497d-87bb-46d6e4dc185a 2026-08-21 Warnings Exact identifier application number: M013 equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Exact identifier application number: M013 aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 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 Marketing end Sample Exclude flag Status 57344-095-01 57344009501 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-07-01 0000-00-00 No No Current 57344-095-02 57344009502 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-10-01 0000-00-00 No No Current 57344-095-03 57344009503 1 BOTTLE, PLASTIC in 1 CARTON (57344-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-11-01 0000-00-00 No No Current 57344-095-12 57344009512 300 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-095-12) 2024-03-12 No No Current