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 37 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cabinet Pain Reliever and Fever Reducer Refill AcetaminophenACETAMINOPHENCabinet Health P.B.C.2744f082-adfd-4dfc-a87d-ed8c0d84a4472025-10-01WarningsExact identifier
application number: M013
ASPIRINASPIRINMarc Glassman, Inc.14cb1d2d-95b8-447e-8d79-e6ec82c0e4312025-10-01WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENProficient Rx LP6794830a-7856-464d-84be-c8b253cf41ac2025-10-01WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINBryant Ranch Prepacke05140fa-9766-4f97-bffc-e36a01b9d38f2025-10-01WarningsExact identifier
application number: M013
Acetaminophen gelcapsACETAMINOPHENTARGET CORPORATION2ea1931e-334e-a551-e063-6394a90a03b92025-09-29WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENTARGET CORPORATION8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb2025-09-29WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3b672ec7-8658-4b43-a79d-094ac8bc69042025-09-29WarningsExact identifier
application number: M013
kirkland signature acetaminophen adult extra strengthACETAMINOPHENCostco Wholesale Companya9979167-1a82-47d7-9602-2865f9bdd6282025-09-27WarningsExact identifier
application number: M013
First Aid Direct Chewable AspirinASPIRINCintas Corpff6960f6-9f55-4f32-9ab5-9187724531e92025-09-25WarningsExact identifier
application number: M013
Bayer Rapid Relief Body PainASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.3fa1ec07-d1a6-226b-e063-6394a90a32132025-09-25WarningsExact identifier
application number: M013
Xpect Chewable AspirinASPIRINCintas Corporationbddce374-1d35-4685-987d-4a4cc99941552025-09-25WarningsExact identifier
application number: M013
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsExact identifier
application number: M013
Xpect Pain Away Extra StrengthACETAMINOPHEN ASPIRIN CAFFEINECintas Corporation1269d069-afaf-4ca5-b369-f74249a348db2025-09-24WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINPreferred Pharmaceuticals Inc.29214eec-860c-43f0-83c6-9ed5a9f530af2025-09-22WarningsExact identifier
application number: M013
ASPIRINASPIRINKroger Companybbee8ee4-e09d-3ba6-e053-2a95a90af6472025-09-19WarningsExact identifier
application number: M013
careone acetaminophenACETAMINOPHENAmerican Sales Company4bb696f6-a47b-4da9-9224-9aeae3e152f32025-09-19WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC49a740ec-8ed4-4c76-b2d0-c13651bafa5e2025-09-18WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEAdvanced Rx LLCa7ed4c76-a5b5-44f7-866f-f43790e45c782025-09-18WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENCVS Pharmacyfc2d4367-8884-4b76-aa3e-8c35be1ace492025-09-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINWalgreen Company5e1484d3-5be1-40da-a3bf-fb19f7d27d452025-09-18WarningsExact 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