FDA.reportPublic FDA data

Acetaminophen

Product NDC
0904-7481
11-digit product format
009047481
Labeler code
0904
Product ID
0904-7481_072e6688-f9f2-409b-8b89-c558e785ba16
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-15
Substance
ACETAMINOPHEN
Active strength
1000 mg/30mL
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
ACETAMINOPHEN1000 mg/30mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7481-59Acetaminophen237 mL in 1 BOTTLE, PLASTICSOLUTION2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7481-59ML - Milliliter0904-7481c028a2ba-5360-4cf3-a565-3fe24c61bfe812025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7481ACETAMINOPHEN SOLUTION [MAJOR PHARMACEUTICALS]1Current NDC, 1 package rows20241009_e1a55e0d-bb86-4515-8436-51a74b403685.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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
application number: M013
Children AcetaminophenACETAMINOPHENAARNA USA INC.25bcb9d5-f388-4ae7-8037-970ffe8d17f02025-05-16WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst35478de8-50d0-5d0a-e063-6294a90a88ba2025-05-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
application number: M013
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSNe1a55e0d-bb86-4515-8436-51a74b4036853
307684acetaminophen 33.3 MG/ML Oral SolutionSCDe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 1000 MG per 30 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 167 MG per 5 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 33.3 MG/ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853
307684APAP 500 MG per 15 ML Oral SolutionSYe1a55e0d-bb86-4515-8436-51a74b4036853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7481-5900904748159237 mL in 1 BOTTLE, PLASTIC (0904-7481-59) 237 ml2021-07-15NoNoCurrent