Home NDC 41163-515 acetaminophen pm
Product NDC 41163-515
11-digit product format 411630515
Labeler code 41163
Product ID 41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-09-01
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 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 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 41163-515-01 acetaminophen pmextra strength 1 in 1 CARTON TABLET, COATED 1 10 41163-515-01 acetaminophen pmextra strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 10 41163-515-02 acetaminophen pmextra strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 10 41163-515-02 acetaminophen pmextra strength 1 in 1 CARTON TABLET, COATED 1 10 41163-515-03 acetaminophen pmextra strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 10 41163-515-03 acetaminophen pmextra strength 1 in 1 CARTON TABLET, COATED 1 10 41163-515-14 acetaminophen pmextra strength 200 in 1 BOTTLE, PLASTIC TABLET, COATED 200 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-515 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI] 10 Current NDC, Legacy NDC, 7 package rows 20241019_f86a11af-6d3c-4638-870d-a663ddf49371.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 43 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coated Aspirin ASPIRIN L.N.K. International, Inc. e077fe14-62bb-462b-bfa3-8a83c06c22f1 2025-07-11 Warnings Exact identifier application number: M013 EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TIME CAP LABS 59482917-f80b-4bed-9218-068b35366eb3 2025-07-11 Warnings Exact identifier application number: M013 Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Exact identifier application number: M013 Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Exact identifier application number: M013 topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Exact identifier application number: M013 equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Exact identifier application number: M013 Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN Advanced Rx LLC ad0d6a5c-eee9-406c-8d7f-1df9b45f5340 2025-07-02 Warnings Exact identifier application number: M013 EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE Lil' Drug Store Products, Inc. ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 2025-07-02 Warnings Exact identifier application number: M013 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE Genexa Inc. 18835205-a9e3-15c2-e063-6394a90a8107 2025-07-02 Warnings Exact identifier application number: M013 FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 11c9712d-c3b2-49cd-9c2b-0f57190c954e 2025-07-02 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN United Natural Foods, Inc. dba UNFI 979973c1-661a-4384-8b92-fd901ebde558 2025-07-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN CVS Pharmacy f6bbce1c-9790-4ca4-847f-579c594ffe0b 2025-07-01 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS 07d2e322-2465-79e5-e063-6294a90a5ea4 2025-06-30 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 66c0cf26-357b-4722-9100-3b86d507a8cd 2025-06-30 Warnings Exact identifier application number: M013 ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE Kroger Company bc019c9e-8fac-5fd3-e053-2a95a90a7ccd 2025-06-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN Extra Strength ACETAMINOPHEN TIME CAP LABS INC fd24d0e0-4f36-42d3-9149-2fb957690305 2025-06-25 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 41163-515-01 41163051501 1 BOTTLE, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-09-01 0000-00-00 No No Current 41163-515-02 41163051502 50 in 1 BOTTLE, PLASTIC Historical 41163-515-03 41163051503 1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-09-01 0000-00-00 No No Current 41163-515-14 41163051514 200 in 1 BOTTLE, PLASTIC Historical