FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
41226-341
11-digit product format
412260341
Labeler code
41226
Product ID
41226-341_584661fe-3b55-4d7d-e063-6294a90acdaa
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kroger Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-20
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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
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
bc17b2e5-4828-6a2e-e053-2995a90a8c63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-341-01ACETAMINOPHEN100 in 1 BOTTLETABLET, COATED1004
41226-341-01ACETAMINOPHEN1 in 1 CARTONTABLET, COATED14
41226-341-10ACETAMINOPHEN1 in 1 PACKAGETABLET, COATED14
41226-341-10ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004
41226-341-15ACETAMINOPHEN150 in 1 BOTTLETABLET, COATED1504
41226-341-50ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-341ACETAMINOPHEN TABLET, COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 6 package rows20240415_bc17b2e5-4828-6a2e-e053-2995a90a8c63.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 TabletPSNbc17b2e5-4828-6a2e-e053-2995a90a8c634
198440acetaminophen 500 MG Oral TabletSCDbc17b2e5-4828-6a2e-e053-2995a90a8c634
198440APAP 500 MG Oral TabletSYbc17b2e5-4828-6a2e-e053-2995a90a8c634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-341-01412260341011 BOTTLE in 1 CARTON (41226-341-01) / 100 TABLET, COATED in 1 BOTTLE1 bottle2021-06-150000-00-00NoNoCurrent
41226-341-10412260341101 BOTTLE in 1 PACKAGE (41226-341-10) / 500 BOTTLE in 1 BOTTLE / 500 TABLET, COATED in 1 BOTTLE1 bottle2021-05-200000-00-00NoNoCurrent
41226-341-1541226034115150 TABLET, COATED in 1 BOTTLE (41226-341-15) 2024-04-15NoNoCurrent
41226-341-5041226034150500 TABLET, COATED in 1 BOTTLE (41226-341-50) 2021-05-200000-00-00NoNoCurrent