FDA.reportPublic FDA data

Acetaminophen

Product NDC
70518-4782
11-digit product format
705184782
Labeler code
70518
Product ID
70518-4782_5ee6e09b-cfa0-c558-e063-6294a90ae452
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-25
Substance
ACETAMINOPHEN
Active strength
325 mg/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06a0fc1f-4cac-4d0f-9349-90a0fb4cc0c8Available on FDA.report

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 29 of 77 · 1,530 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact identifier
application number: M013
Bayer Rapid ReliefASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.f1fecbb0-5b55-fe8f-e053-2995a90a09772025-12-05WarningsExact identifier
application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-ElevenACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATEDLil' Drug Store Products, Inc.45381b1c-2acd-1524-e063-6394a90a83d92025-12-05WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI729132cd-f209-447a-8949-a90b5a5c01da2025-12-05WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp05fda811-d65f-41b2-89e4-297cdddb3d992025-12-05WarningsExact identifier
application number: M013
aspirinASPIRINHealth Pharma USA, LLC3165b0a3-556b-6abe-e063-6394a90a76822025-12-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINBayer HealthCare LLC.44a08904-68b9-4d06-a28d-21aae3d6140c2025-12-04WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
application number: M013
Bayer HeadacheASPIRIN AND CAFFEINEBayer HealthCare LLC.c0a92873-0914-6a86-e053-2995a90ac41c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORBayer HealthCare LLC.07478020-5ba0-3b67-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.78537dcf-b157-4b67-a8b2-5cb1448151662025-12-04WarningsExact identifier
application number: M013
BAYER Aspirin Extra Strength CapletsBAYER ASPIRIN EXTRA STRENGTHBayer HealthCare LLC.0ae64cdb-4ea0-23af-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry FlavoredASPIRINBayer HealthCare LLC.070d5713-e018-2913-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4782-07051847820060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4782-0) 2026-10-25NoNoCurrent
70518-4782-170518478201120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4782-1) 2026-10-28NoNoCurrent