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 53 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAFIZETAMOL FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028771d3-a514-f7a5-e063-6394a90ac4f3 2024-12-03 Warnings Exact identifier application number: M013 Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 048c4b03-1cf4-b724-e063-6294a90a1cad 2024-12-03 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC ecd6df7e-e7e2-446b-85ef-25971281fe31 2024-12-03 Warnings Exact identifier application number: M013 Market Basket Effervescent Pain Relief ASPIRIN DEMOULAS SUPER MARKETS, INC. 08133bf0-3c8f-e4d0-e063-6294a90af79a 2024-12-03 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN WinCo Foods, LLC 4359da13-e851-440b-91b9-6b544bff20d2 2024-12-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN WinCo Foods, LLC 5b3e8a78-5357-42ad-811e-b2578b25dc7b 2024-12-03 Warnings Exact identifier application number: M013 Low Strength Chewable Aspirin ASPIRIN Geri-Care Pharmaceutical Corp cc77b9d1-7874-4ce8-a763-3a0e1c2891de 2024-12-03 Warnings Exact identifier application number: M013 Good Sense Childrens Pain and Fever ACETAMINOPHEN L. Perrigo Company c6b79501-d08b-4430-9545-70da5f545975 2024-12-03 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 2024-12-02 Warnings Exact identifier application number: M013 St. Joseph Chewable Low Dose Aspirin ASPIRIN Foundation Consumer Healthcare LLC 248cd302-e380-4837-bdae-9df620b67e8a 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN AAA Pharmaceutical, Inc. 2d98e390-4f2a-41cc-b307-3d2f6a3700dd 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE AAA Pharmaceutical, Inc. 409b5fcd-5880-4dda-85d8-26aeceb4f8ab 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN AAA Pharmaceutical, Inc. c0c31523-c4c5-43c2-8d72-4d1456c720e9 2024-12-02 Warnings Exact identifier application number: M013 NOTTS - Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE VIVUNT PHARMA LLC e6754f62-e3b2-773f-e053-2a95a90ad36a 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AAA Pharmaceutical, Inc. a891896d-c9fa-4448-915a-e6b531157d22 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN SAFEWAY d2d15e06-e9eb-3d2b-e053-2995a90a1cec 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN TopCo Associates LLC c2d33352-431c-4683-a4fa-a54437e7b8d2 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb 2024-12-02 Warnings Exact identifier application number: M013 Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc c4473ee6-4e01-1ec2-e053-2995a90ac513 2024-12-02 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