FDA.reportPublic FDA data

Acetaminophen

Product NDC
68071-5239
11-digit product format
680715239
Labeler code
68071
Product ID
68071-5239_2a95afd1-cd26-371c-e063-6294a90a97d4
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Pain Relief
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-01-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
a32f346e-71d0-cc11-e053-2a95a90ae88cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5239-92022-02-07C16284748780-1d6a99b39-bd7b-a426-e053-dadaa90af4c2gc201
68071-5239-92022-01-28C16284748780-1d6a99b39-bd7b-a426-e053-dadaa90af4c2gc201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5239-3Acetaminophen30 in 1 BOTTLETABLET307
68071-5239-5Acetaminophen45 in 1 BOTTLETABLET457
68071-5239-9Acetaminophen90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5239ACETAMINOPHEN (EXTRA STRENGTH PAIN RELIEF) TABLET [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20250101_a32f346e-71d0-cc11-e053-2a95a90ae88c.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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
application number: M007
Senna LiquidSENNOSIDESRUGBY LABORATORIES8123b092-2ae9-459b-ae06-6ceb837adcf82025-12-30WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDERUGBY LABORATORIESb1bafa6e-0f54-1c35-e053-2995a90a42e42025-12-30WarningsExact identifier
application number: M007
OneLAX SENNASENNAATLANTIC BIOLOGICALS CORP.d2a5a13a-e7e4-488a-b60b-4dd467efa9712025-12-29WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESLlorens Pharmaceutical International Division, Inc.5be0163c-b7f7-46db-b738-78c2946a6cf62025-12-29WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.c18dd7fa-993b-440b-8cdd-f1551abb99ca2025-12-29WarningsExact identifier
application number: M007
LAXATIVEBISACODYLGRAXCELL PHARMACEUTICAL, LLC5a65d4ab-447f-42bb-b38d-070db523b8062025-12-25WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
application number: M007
Senna TabsSENNAPharbest Pharmaceuticals, Inc.b9f8ea59-932f-4827-a87c-b4aff909c43f2025-12-24WarningsExact identifier
application number: M007
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
application number: M007
Equate Gentle Laxative Soft chewMAGNESIUM HYDROXIDEWalmart0997c1b7-16db-7db7-e063-6294a90a59282025-12-23WarningsExact identifier
application number: M007
Equate Kids Gentle Laxative SCMAGNESIUM HYDROXIDEWalmart1662a542-aef0-9087-e063-6294a90aa6d92025-12-23WarningsExact identifier
application number: M007
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
application number: M007
AMAZON FIBER THERAPYMETHYLCELLULOSEAMAZON.COM SERVICES LLC3eee7b21-5401-4ef1-b1c6-1013439639d22025-12-22WarningsExact identifier
application number: M007
SennosidesSENNOSIDESGranules USA Inca619b8f4-1b5d-181b-e053-2995a90ab7292025-12-22WarningsExact identifier
application number: M007
CAREALL SennosidesSENNOSIDESNew World Imports, Inc61bbbb6a-9997-4df1-94be-a80686d1f1b92025-12-22WarningsExact identifier
application number: M007
Walgreens Blueberry Raspberry Gentle LaxativeMAGNESIUM HYDROXIDEWalgreend35f1518-bc63-83eb-e053-2995a90ae4bb2025-12-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESWalgreens Co85a2f7ed-315e-2403-e053-2991aa0abdce2025-12-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESH E Ba5652d5b-43fd-5bfa-e053-2995a90aad6c2025-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa32f346e-71d0-cc11-e053-2a95a90ae88c7
198440acetaminophen 500 MG Oral TabletSCDa32f346e-71d0-cc11-e053-2a95a90ae88c7
198440APAP 500 MG Oral TabletSYa32f346e-71d0-cc11-e053-2a95a90ae88c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5239-36807152390330 TABLET in 1 BOTTLE (68071-5239-3) 30 tablet2020-04-13NoNoCurrent
68071-5239-56807152390545 TABLET in 1 BOTTLE (68071-5239-5) 45 tablet2020-04-130000-00-00NoNoCurrent
68071-5239-96807152390990 TABLET in 1 BOTTLE (68071-5239-9) 90 tablet2020-04-130000-00-00NoNoCurrent