FDA.reportPublic FDA data

Acetaminophen

Product NDC
72476-104
11-digit product format
724760104
Labeler code
72476
Product ID
72476-104_092d4d23-3773-2281-e063-6294a90aa7e9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RETAIL BUSINESS SERVICES , LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-20
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
eb644e9e-36dc-5f84-e053-2a95a90affa5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-104-01Acetaminophen24 in 1 BOTTLE, PLASTICTABLET, COATED242
72476-104-01Acetaminophen1 in 1 CARTONTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-104ACETAMINOPHEN TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.]2Current NDC, 2 package rows20231103_eb644e9e-36dc-5f84-e053-2a95a90affa5.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 34 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalmart Inc.1557bd9b-3e7c-4769-e063-6394a90a9d912025-11-04WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINRising Pharma Holdings, Inc.c3c4854e-726e-4926-b044-a5094943c3062025-11-04WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e50b3f6-1e1a-41b9-e063-6394a90abe362025-11-03WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company447de441-7d28-4415-81c5-4fc05622dd052025-11-03WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENVERITYRX. LLC42a17f54-7851-84fb-e063-6394a90a9ec12025-11-02WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENVERITYRX, LLC42a1a128-a2dd-bbc9-e063-6294a90a4fe12025-11-02WarningsExact identifier
application number: M013
Physicians Care AspirinASPIRINAcme United Corporationaa67ea3a-2741-7ee0-e053-2a95a90a64852025-10-31WarningsExact identifier
application number: M013
PhysiciansCare Non Aspirin Extra StrengthACETAMINOPHENAcme United Corporationc7006775-bd5b-412f-963d-ce5a158216c52025-10-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreensf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba2025-10-31WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENNuCare Pharmaceuticals, Inc.41affa1a-5aac-7fc0-e063-6394a90a55572025-10-30WarningsExact identifier
application number: M013
MAPAP Extra StrengthACETAMINOPHENMajor Pharmaceuticals34a95450-3f04-4de4-9113-73e7bd5724a02025-10-29WarningsExact identifier
application number: M013
GOODNOW PAIN RELIEFACETAMINOPHENGobrands, Inc4d4a78a5-5a88-4f24-b685-c7c6bb5e989e2025-10-29WarningsExact identifier
application number: M013
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.f8237772-7656-49fb-b1de-f8fcb5fa55ee2025-10-28WarningsExact identifier
application number: M013
DG Health Pain ReliefACETAMINOPHENDolgencorp Inc42f0c87c-7020-4af7-9f6b-3a774137e5642025-10-24WarningsExact identifier
application number: M013
GOODYS HangoverASPIRIN AND CAFFEINEMedtech Products Inc.0b0067e0-58b0-4581-aa4b-e398c32c559a2025-10-23WarningsExact identifier
application number: M013
GOODYS Extra Strength Headache Mixed Fruit BlastACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.6cb758bf-5a50-46bb-96e7-65b810b12de02025-10-23WarningsExact identifier
application number: M013
Nyt Time Sleep CapsDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MARTe3f4d063-921d-4503-89a6-26cc9c46b4c92025-10-23WarningsExact identifier
application number: M013
AnacinASPRIN AND CAFFEINEInsight Pharmaceuticals LLC51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff2025-10-23WarningsExact identifier
application number: M013
Goodys Back and Body PainACETAMINOPHEN AND ASPRINMedtech Products Inc.055d0288-61d4-48bc-b91f-6ecc1969beb82025-10-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNeb644e9e-36dc-5f84-e053-2a95a90affa52
198440acetaminophen 500 MG Oral TabletSCDeb644e9e-36dc-5f84-e053-2a95a90affa52
198440APAP 500 MG Oral TabletSYeb644e9e-36dc-5f84-e053-2a95a90affa52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72476-104-01724760104011 BOTTLE, PLASTIC in 1 CARTON (72476-104-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-01-20NoNoCurrent