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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECardinal Health (Leader) 70000cde87f95-73c0-46f5-9349-37e04096048c2025-01-22WarningsExact identifier
application number: M007
Senna-TabsSENNA 8.6MGUlai Health LLC485129a0-8340-4f61-be51-5abff5032b8d2025-01-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
application number: M007
Soluble FiberMETHYLCELLULOSEUnited Natural Foods, Inc. dba UNFI6decd5ef-e8e1-44ae-8465-6266cf18e81e2025-01-20WarningsExact identifier
application number: M007
PerdiemSENNOSIDES, STIMULANT LAXATIVEHaleon US Holdings LLC6b256c8f-3953-4c69-9a16-ffa0511bdbcd2025-01-16WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESEverpharm LLC0ea9f2b5-4533-4b71-b019-10ecb3c064592025-01-16WarningsExact identifier
application number: M007
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
application number: M007
SennaSENNOSIDESReliable 1 Laboratories LLCae46a611-20f2-74c8-e053-2995a90a32ce2025-01-15WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs4d678da0-9ada-4d00-9db9-33b45c7761072025-01-15WarningsExact identifier
application number: M007
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
application number: M007
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGUlai Health LLCc0e27b02-8ef2-4239-8f8c-790f7d978dc02025-01-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals1541ff5b-11f8-444b-a2a0-8e3086ae650a2025-01-10WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAvPAKf31a4349-7826-45c0-9388-6b938d167b7a2025-01-09WarningsExact identifier
application number: M007
Docusate sodiumDOCUSATE SODIUMAPNAR PHARMA LP05b0732b-012f-78ee-e063-6294a90a839a2025-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMMcKessone5fdfcfd-5340-4929-9f68-2696110cca8e2025-01-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact 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