FDA.reportPublic FDA data

Acetaminophen

Product NDC
57237-347
Requested package NDC
57237-347-01
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 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
application number: M013
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALGREENS40b4fe91-b1dd-147c-e063-6294a90a807d2026-06-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
application number: M013
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
application number: M013
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINRugby Laboratories63fcd93a-b1db-44ba-8f2b-055a7deb205d2026-06-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
application number: M013
Aspirin Adult low doseACETYLSALICYCLIC ACIDMedline Industries, LP6dd6501f-841c-4994-e053-2a91aa0ae2312026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECVS Pharmacy749e2be2-594a-4052-8fa5-45c9ade2d23c2026-06-03WarningsExact 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