FDA.reportPublic FDA data

Acetaminophen

Product NDC
72036-104
11-digit product format
720360104
Labeler code
72036
Product ID
72036-104_5852bc1b-5799-ea43-e063-6394a90a73fa
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HARRIS TEETER
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72036-10472036-104-06DDiscontinued by firm2026-10-05

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
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
960f5676-d8c5-470b-a663-4b8d152339b4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72036-104-01Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-01Acetaminophen24 in 1 BOTTLE, PLASTICTABLET, COATED245
72036-104-02Acetaminophen50 in 1 BOTTLE, PLASTICTABLET, COATED505
72036-104-02Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-04Acetaminophen1 in 1 CARTONTABLET, COATED15
72036-104-04Acetaminophen100 in 1 BOTTLE, PLASTICTABLET, COATED1005
72036-104-06Acetaminophen500 in 1 BOTTLE, PLASTICTABLET, COATED5005
72036-104-08Acetaminophen150 in 1 BOTTLE, PLASTICTABLET, COATED1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-104ACETAMINOPHEN TABLET, COATED [HARRIS TEETER]4Current NDC, Legacy NDC, 8 package rows20241024_960f5676-d8c5-470b-a663-4b8d152339b4.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 7 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINDOLGENCORP, LLC955484a6-2a7a-4b15-a9b4-e888ed5de04c2026-07-15WarningsExact identifier
application number: M013
AspirinASPIRINGeri-Care Pharmaceuticals, Corp58941782-362d-4436-b365-e909bdbd29a22026-07-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINMajor Pharmaceuticals44730dfb-5062-4015-924b-c30b6c2b19c22026-07-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leaderf1cd0d59-12a8-4ff2-942a-6faa6907ef052026-07-13WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergen2c5e80e8-a979-45fb-9297-8ff294280c252026-07-13WarningsExact identifier
application number: M013
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN960f5676-d8c5-470b-a663-4b8d152339b45
198440acetaminophen 500 MG Oral TabletSCD960f5676-d8c5-470b-a663-4b8d152339b45
198440APAP 500 MG Oral TabletSY960f5676-d8c5-470b-a663-4b8d152339b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72036-104-01720360104011 BOTTLE, PLASTIC in 1 CARTON (72036-104-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-02720360104021 BOTTLE, PLASTIC in 1 CARTON (72036-104-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-04720360104041 BOTTLE, PLASTIC in 1 CARTON (72036-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2011-12-010000-00-00NoNoCurrent
72036-104-0672036010406500 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-104-06) 2012-01-010000-00-00NoNoCurrent
72036-104-0872036010408150 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-104-08) 2013-06-010000-00-00NoNoCurrent