FDA.reportPublic FDA data

acetaminophen

Product NDC
11673-838
11-digit product format
116730838
Labeler code
11673
Product ID
11673-838_3feb273f-9713-576d-e063-6294a90aaad4
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TARGET CORPORATION
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
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
8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-838-01acetaminophen100 in 1 BOTTLETABLET, COATED1004
11673-838-05acetaminophen50 in 1 BOTTLETABLET, COATED504
11673-838-10acetaminophen2 in 1 CARTONTABLET, COATED24
11673-838-26acetaminophen225 in 1 BOTTLETABLET, COATED2254
11673-838-50acetaminophen500 in 1 BOTTLETABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-838ACETAMINOPHEN TABLET, COATED [TARGET CORPORATION]3Current NDC, Legacy NDC, 5 package rows20240927_8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb.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 77 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENSf3c69974-7f51-2227-e053-2995a90a55702023-10-21WarningsExact identifier
application number: M013
Menstrual CompleteMENSTRUAL COMPLETEHealthlife of USAc7e89b01-a8eb-4487-8f0b-a4b9ae6d9f332023-10-21WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corpe65dbd01-2d5e-4067-ad98-98d879cfb5ee2023-10-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb4
198440acetaminophen 500 MG Oral TabletSCD8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb4
198440APAP 500 MG Oral TabletSY8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-838-0111673083801100 TABLET, COATED in 1 BOTTLE (11673-838-01) 2020-01-010000-00-00NoNoCurrent
11673-838-051167308380550 TABLET, COATED in 1 BOTTLE (11673-838-05) 2020-01-010000-00-00NoNoCurrent
11673-838-10116730838102 BOTTLE in 1 CARTON (11673-838-10) / 500 TABLET, COATED in 1 BOTTLE (11673-838-50) 2 bottle2020-01-01NoNoCurrent
11673-838-2611673083826225 TABLET, COATED in 1 BOTTLE (11673-838-26) 2020-01-010000-00-00NoNoCurrent
11673-838-5011673083850500 TABLET, COATED in 1 BOTTLE (11673-838-50) 2020-01-010000-00-00NoNoCurrent