FDA.reportPublic FDA data

Acetaminophen Diphenhydramine HCL

Product NDC
75907-431
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
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE25 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 32 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC422796ed-7558-f7e8-e063-6294a90ad1c72025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e61abe4-b4be-01af-e063-6394a90a8b242025-11-20WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
application number: M013
ASPIRINASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED54e4ae54-caf8-4105-8428-256f56a2f68f2025-11-19WarningsExact identifier
application number: M013
MIDOL COMPLETEACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATER J General Corporation0c09a178-1a07-4079-b4a6-d1657cb8e7142025-11-17WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
application number: M013
MOTRIN IBIBUPROFENR J General Corporationafa87bb5-7fcb-4ccd-acac-f7931242181f2025-11-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENR J General Corporation99e45e83-37a3-44df-9a2a-98ba7457a5bb2025-11-17WarningsExact identifier
application number: M013
TYLENOL PM EXTRA STRENGTHACETAMINOPHENR J General Corporationa40ea0e3-d666-4605-b5e0-beeaf8f586f22025-11-17WarningsExact identifier
application number: M013
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MGR J General Corporation68d3be55-9340-4cc9-a05a-12b9338ddc562025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationdd9aaf80-6c2b-41a3-87b9-61642aaed4f02025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c18a2da-1718-4c00-aea8-9fb4a34183122025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationcd3060a5-3b90-42e4-89cd-3b620859045f2025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c7221ae-52d1-4d18-b586-c47ff656150d2025-11-17WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINER J General Corporation907c89e7-2482-465f-9f85-2381ecab1b862025-11-17WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINR J General Corporation23daa359-d40f-4f64-81be-6d154f41df9f2025-11-17WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-431-01759070431011 BOTTLE in 1 CARTON (75907-431-01) / 100 TABLET in 1 BOTTLE1 bottle2026-09-25NoNoCurrent
75907-431-3075907043130300 TABLET in 1 BOTTLE (75907-431-30) 300 tablet2026-09-25NoNoCurrent