FDA.reportPublic FDA data

NDC 68071-3579-01 - Sulfamethoxazole and Trimethoprim

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3579
Requested NDC
68071-3579-01
Package NDCs from labels
68071-3579-1, 68071-3579-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim Tablets, USPNuCare Pharmaceuticals,Inc.2025-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3579-1Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3579SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240229_1274cefb-0799-e2e4-e063-6394a90aad02.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 9 of 22 · 440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMMajor Pharmaceuticalsabe0d2d5-4879-4b4e-9b57-47ea83a17ba02025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLCa7fa9a4b-0fa3-4003-bfb1-8f26ca7109892025-11-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
unii: F05Q2T2JA0
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy1ed3a4d3-629c-4d70-ac03-d0db9f77a9c82025-11-06WarningsExact identifier
unii: F05Q2T2JA0
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreens765bfd9b-7a21-4315-9add-cf13007722d52025-10-31WarningsExact identifier
unii: F05Q2T2JA0
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY71b15339-2585-4fae-8445-6fbb4f0a378e2025-10-31WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVERITYRX, LLC427b8040-99a4-8e81-e063-6394a90a76c52025-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESFamily Dollar (FAMILY WELLNESS)1eee3ed5-09f7-44a9-abc5-98336e493fe82025-10-30WarningsExact identifier
unii: F05Q2T2JA0
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.1274cefb-0799-e2e4-e063-6394a90aad022025-10-07Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (package): 68071-3579-1
ndc (product): 68071-3579
ndc11 (package): 68071357901
spl id: 40980007-9cca-cbda-e063-6394a90a23b3
spl set id: 1274cefb-0799-e2e4-e063-6394a90aad02
unii: AN164J8Y0X
unii: JE42381TNV
Stool SoftenerDOCUSATE SODIUMPreferred Pharmaceuticals Inc.1d9fa4b9-3ec2-4ea2-a05a-ca46cc5291672025-10-01WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
unii: F05Q2T2JA0
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.