Acetaminophen

Product NDC
57237-347
11-digit product format
572370347
Labeler code
57237
Product ID
57237-347_ffbb6e36-399b-40eb-96b4-b0406c712c0d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-09
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8237772-7656-49fb-b1de-f8fcb5fa55eeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-347-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED1002
57237-347-05Acetaminophen500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-347-01EA - Each57237-3474f6789ab-9c2c-4ac7-a464-2a6e97d0c88b12025-08-11
57237-347-05EA - Each57237-34787c5b2bc-2c08-4480-8a77-b1524ea59b1312025-11-13

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 13 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.5220a40d-4a4f-5bad-e063-6394a90a93b02026-05-18WarningsExact identifier
application number: M013
childrens Pain and FeverACETAMINOPHENTopco Associates, LLC7f7b4377-9b40-4a12-808b-f1cd7d241b0d2026-05-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINGendose Pharmaceuticals, LLC10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa2026-05-15WarningsExact identifier
application number: M013
AspirinASPIRINGendose Pharmaceuticals, LLC119de26f-cce5-401c-81fa-775ebebf6c6f2026-05-15WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINCardinal Health 107, LLC827bbe77-febb-4352-892f-3fbb2acfc7d52026-05-14WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC56c125de-fabf-41fa-88a4-760d2793f2022026-05-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEChain Drug Marketing Association, Inc.17216bf3-bed0-4d7a-994e-76a0e4c79c5c2026-05-13WarningsExact identifier
application number: M013
childrens pain relieverACETAMINOPHENValu Merchandisers Company1d3584e3-f128-4441-b842-aba45053ea532026-05-12WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutionsc445c6bb-69a8-492e-b100-ce942707f2032026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Company1754a9f2-e7e5-4efb-a728-6ba2a7155d112026-05-12WarningsExact identifier
application number: M013
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATETarget Corporationbc65e205-64fd-4764-8c5e-2793af4e9adf2026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLCa7e27000-a26b-46c2-823e-663f4e76db742026-05-11WarningsExact identifier
application number: M013
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
application number: M013
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf8237772-7656-49fb-b1de-f8fcb5fa55ee2
198440acetaminophen 500 MG Oral TabletSCDf8237772-7656-49fb-b1de-f8fcb5fa55ee2
198440APAP 500 MG Oral TabletSYf8237772-7656-49fb-b1de-f8fcb5fa55ee2
198440acetaminophen 500 MG Oral TabletPSNf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161
198440acetaminophen 500 MG Oral TabletSCDf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161
198440APAP 500 MG Oral TabletSYf32fc2e9-c0e3-4a25-8399-9cdba6ae8a161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57237-347-0157237034701100 TABLET, FILM COATED in 1 BOTTLE (57237-347-01) 2025-07-09NoNoCurrent
57237-347-0557237034705500 TABLET, FILM COATED in 1 BOTTLE (57237-347-05) 2025-11-04NoNoCurrent