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 70 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC a71074a6-cc19-4bb3-8c84-4e82a8906801 2024-04-22 Warnings Exact identifier application number: M013 Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Exact identifier application number: M013 Regular Strength Aspirin 325 mg ASPIRIN Kroger 0fc3193d-af4e-ff3a-e063-6294a90a2743 2024-04-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Exact identifier application number: M013 aspirin low dose chewable ASPIRIN Time-Cap Labs, Inc 5d56618c-8ea2-42ea-a9f2-339bd0055ddd 2024-04-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN P & L Development, LLC 0058175f-3474-40c3-a046-6cfaec86d84b 2024-04-16 Warnings Exact identifier application number: M013 Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Navajo Manufacturing Company Inc. e5481abe-6971-2bc5-e053-2995a90ae895 2024-04-15 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Exact identifier application number: M013 infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Exact identifier application number: M013 Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 Warnings Exact identifier application number: M013 Mommys Bliss Infants Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 05e26650-81b3-d7b1-e063-6394a90a14ed 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief CHILDRENS PAIN RELIEF Allegiant Health 7381dd26-c507-4d02-b989-cfd96e02f495 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief Dye-Free ACTEAMINOPHEN WinCo Foods, LLC 5ee134b3-b8e9-4621-b0a1-a84d9867ccba 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN WALGREENS 0b1d086f-7be1-5072-e063-6394a90a11e6 2024-04-10 Warnings Exact identifier application number: M013 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
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