FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-931
11-digit product format
698420931
Labeler code
69842
Product ID
69842-931_4f2412fc-ac45-48f3-bc00-9c1f9e30cec6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS PHARMACY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-11
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
Brand name suffix
Extra Strength
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
64a1ebe7-af28-4b09-96e8-28fa4dcc52bdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-931-08AcetaminophenExtra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2417
69842-931-08AcetaminophenExtra Strength1 in 1 CARTONTABLET, FILM COATED117
69842-931-17AcetaminophenExtra Strength300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30017
69842-931-29AcetaminophenExtra Strength150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-931-08EA - Each69842-93180c1fc42-8331-4289-a21f-a730e84a287f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-931ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [CVS PHARMACY]16Current NDC, Legacy NDC, 4 package rows20250519_64a1ebe7-af28-4b09-96e8-28fa4dcc52bd.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.562d7901-44d6-4d9b-be8b-a8d468a22c432026-02-13WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
application number: M013
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
application number: M013
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINSportpharm LLCd3379569-7949-4f78-b634-5d4178b21ea42026-02-06WarningsExact identifier
application number: M013
Buffered AspirinASPIRINCardinal Health 110, LLC. DBA Leadere5f68c1a-21f3-45a1-861f-229a95b3721c2026-02-06WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
application number: M013
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
application number: M013
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
application number: M013
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN64a1ebe7-af28-4b09-96e8-28fa4dcc52bd17
198440acetaminophen 500 MG Oral TabletSCD64a1ebe7-af28-4b09-96e8-28fa4dcc52bd17
198440APAP 500 MG Oral TabletSY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-931-08698420931081 BOTTLE, PLASTIC in 1 CARTON (69842-931-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2005-12-110000-00-00NoNoCurrent
69842-931-1769842093117300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69842-931-17) 2005-12-110000-00-00NoNoCurrent
69842-931-2969842093129150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69842-931-29) 2005-12-112027-01-31NoNoCurrent