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 44 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
application number: M013
AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.696f55b1-536c-40c4-91f7-b572c39220db2025-06-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC372be427-acbd-c10c-e063-6294a90a572d2025-06-09WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
application number: M013
Dolo-NeuroBionACETAMINOPHENBENARD INDUSTRIES INCb8310770-84d1-4a6f-8e23-9974947f92f12025-06-04WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENP & L Development, LLCb815fcae-8bba-4737-ac10-29a32fb692752025-05-30WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKinderFarms, LLC81cc4900-226b-4c49-ba9c-5747d2a501b12025-05-29WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBryant Ranch Prepacke08a7ab1-4b68-422a-97bd-2c53266339432025-05-29WarningsExact identifier
application number: M013
Acetaminophen GelcapsACETAMINOPHENKroger30d3f2d0-da35-7f6f-e063-6294a90a9c222025-05-23WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.fcffa7e6-145c-6bc0-e053-6294a90a47512025-05-23WarningsExact 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