Home NDC 75907-431-01 Acetaminophen Diphenhydramine HCL
Product NDC 75907-431
Requested package NDC 75907-431-01
11-digit product format 759070431
Labeler code 75907
Product ID 75907-431_d948fa6f-21f3-1861-6421-e5642bf8e4d3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-25
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
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 Acetaminophen Diphenhydramine HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE 25 mg/1
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 64 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain and Fever ACETAMINOPHEN H E B 86a072a9-c3b8-47f7-8598-d66e3d30e762 2024-08-21 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Kroger Company d965eba0-b268-41b2-8e02-5f6d769a44d7 2024-08-18 Warnings Exact identifier application number: M013 equate pain and fever childrens ACETAMINOPHEN Wal-Mart Stores Inc ea68d735-c677-4280-a3a3-ae3eb5ff7462 2024-08-17 Warnings Exact identifier application number: M013 childrens pain and fever ACETAMINOPHEN CVS Pharmacy fac408f0-ebb6-4c72-88ee-2ba85867859c 2024-08-16 Warnings Exact identifier application number: M013 Regular Strength Pain Relief ACETAMINOPHEN Bryant Ranch Prepack 3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad24 2024-08-14 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief - Extra Strength ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 1f926637-a61c-8eb7-e063-6394a90a6502 2024-08-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma 6ec12573-03d6-40c1-9945-d345b401e062 2024-08-12 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company eacee273-abd7-4ea4-bcaa-7f74abcc9feb 2024-08-07 Warnings Exact identifier application number: M013 infants pain and fever ACETAMINOPHEN Kroger Company 7dbe284a-c0d5-4ac4-8445-611610f3c0fb 2024-08-02 Warnings Exact identifier application number: M013 Dollar General Effervescent Pain Reliever ASPIRIN Dolgencorp, Inc 1deab362-a325-3a00-e063-6294a90a9acd 2024-08-01 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN FSA STORE INC. 1cd6a3e6-1376-0b7b-e063-6394a90af3d1 2024-07-30 Warnings Exact identifier application number: M013 pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Publix Super Markets Inc 42d271b7-b45f-4497-8de2-4e05b4bebfa9 2024-07-17 Warnings Exact identifier application number: M013 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75907-431-01 75907043101 1 BOTTLE in 1 CARTON (75907-431-01) / 100 TABLET in 1 BOTTLE 1 bottle 2026-09-25 No No Current