Acetaminophen

Product NDC
84269-2522
11-digit product format
842692522
Labeler code
84269
Product ID
84269-2522_35f6a135-2698-41bb-956f-0f76402dae34
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Wildman Business Group
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
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
943c8f49-e65e-40bc-b364-3274df4d21a2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-2522-1Acetaminophen2 in 1 PACKETTABLET21
84269-2522-1Acetaminophen50 in 1 BOXTABLET501
84269-2522-2Acetaminophen125 in 1 BOXTABLET1251
84269-2522-2Acetaminophen2 in 1 PACKETTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84269-2522ACETAMINOPHEN TABLET [WILDMAN BUSINESS GROUP]1Current NDC, 4 package rows20240523_943c8f49-e65e-40bc-b364-3274df4d21a2.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 36 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
application number: M013
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)f8e5fab4-1212-4c60-a160-9b782f76a1982025-10-03WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3d71a0aa-5e03-0bdc-e063-6294a90a66342025-10-02WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepack8e40f8f1-03c5-444b-8b5e-4532c3146e472025-10-02WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINProficient Rx LP9f9355f7-024a-4adc-bb4c-2d9c0dd0cb772025-10-01WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN943c8f49-e65e-40bc-b364-3274df4d21a21
198440acetaminophen 500 MG Oral TabletSCD943c8f49-e65e-40bc-b364-3274df4d21a21
198440APAP 500 MG Oral TabletSY943c8f49-e65e-40bc-b364-3274df4d21a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84269-2522-18426925220150 PACKET in 1 BOX (84269-2522-1) / 2 TABLET in 1 PACKET50 packet2024-05-20NoNoCurrent
84269-2522-284269252202125 PACKET in 1 BOX (84269-2522-2) / 2 TABLET in 1 PACKET125 packet2024-05-20NoNoCurrent