Home NDC 41163-956 Acetaminophen PM
Product NDC 41163-956
11-digit product format 411630956
Labeler code 41163
Product ID 41163-956_341c4641-167b-42ef-998a-9e2a0df7404b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-12-17
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
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 · 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 41163-956-09 Acetaminophen PMExtra Strength 20 in 1 BOTTLE, PLASTIC TABLET, COATED 20 16 41163-956-09 Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 41163-956-10 Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 41163-956-10 Acetaminophen PMExtra Strength 40 in 1 BOTTLE, PLASTIC TABLET, COATED 40 16 41163-956-31 Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 41163-956-31 Acetaminophen PMExtra Strength 80 in 1 BOTTLE, PLASTIC TABLET, COATED 80 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [SUPERVALU INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-956 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI] 15 Current NDC, Legacy NDC, 6 package rows 20250217_ae3114c3-8cfe-4b81-8ac7-c281fe68b462.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 65 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join basic care acetaminophen pm ACETAMINOPHEN, DIPHENHYDRAMINE HCL Amazon.com Services LLC 64a0084a-e29e-4c1a-8704-13a3e1238f76 2024-07-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Walmart Inc. 152c013a-c81c-f8f9-e063-6294a90a9f23 2024-07-15 Warnings Exact identifier application number: M013 Diphenhydramine HCL DIPHENHYDRAMINE HCL NuCare Pharmaceuticals, Inc. 5411544e-3c2d-4e42-e054-00144ff8d46c 2024-07-10 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L. Perrigo Company b97c51ad-4953-4491-9ceb-395550eb5296 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 065e6f1b-f68c-491a-a157-84961a07e3d9 2024-07-10 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Walgreens 3b7b6725-2996-44d3-89a3-032384e7e2ce 2024-07-10 Warnings Exact identifier application number: M013 equate pain and fever infants ACETAMINOPHEN Wal-Mart Stores Inc 8a152c8d-8ae0-4201-8bb9-7b22c3577415 2024-07-10 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WinCo Foods, LLC 3c57498c-86b0-4ba3-881e-c742a2e8ece5 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WinCo Foods, LLC c358d1dd-9fcb-4d18-9521-8f898b98a732 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN WinCo Foods, LLC 15430025-f25e-4fe7-b1fe-4eda4684081a 2024-07-09 Warnings Exact identifier application number: M013 Acetaminophen Easy Tabs Extra Strength ACETAMINOPHEN WinCo Foods, LLC 0631f003-4852-4034-a1c5-1552804b1660 2024-07-09 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Bryant Ranch Prepack 61ecf3c9-42fa-4ae4-bd3b-694090477b9a 2024-07-09 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC fa0ce51f-441d-4409-8617-b3402b00f187 2024-07-08 Warnings Exact identifier application number: M013 Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 81d4e8f5-2f15-462b-be71-ef05f0b791ab 2024-07-05 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 31a97a6a-e5c8-429a-b497-330f0d84777d 2024-07-05 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Meijer Distribution Inc 375b2142-3c89-469c-98fd-bd4b63aeaa11 2024-07-05 Warnings Exact identifier application number: M013 Best Choice Effervescent Pain Reliever 36 ASPIRIN VALU MERCHANDISERS COMPANY 12f1278e-88b6-0460-e063-6394a90abf0e 2024-07-03 Warnings Exact identifier application number: M013 Topcare pain and fever ACETAMINOPHEN Topco Associates LLC 950b16d5-65db-402d-8ec6-eec9e1e174dd 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN WALMART INC. 16d5b56f-7e56-0c91-e063-6394a90a4b8e 2024-07-03 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALMART INC. 16d5786c-2346-f970-e063-6394a90a0a8c 2024-07-03 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 41163-956-09 41163095609 1 BOTTLE, PLASTIC in 1 CARTON (41163-956-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 2007-12-17 0000-00-00 No No Current 41163-956-10 41163095610 1 BOTTLE, PLASTIC in 1 CARTON (41163-956-10) > 40 TABLET in 1 BOTTLE, PLASTIC 2007-12-17 0000-00-00 No No Current 41163-956-31 41163095631 1 in 1 CARTON Historical