FDA.reportPublic FDA data

NDC 76420-405 - 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
76420-405
Package NDCs from labels
76420-405-06, 76420-405-10, 76420-405-14, 76420-405-20, 76420-405-28, 76420-405-30, 76420-405-01, 76420-405-05
Manufacturer
ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOCUSATE SODIUM - ASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEMASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM2025-06-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-405-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1001
76420-405-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET5001
76420-405-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET61
76420-405-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET101
76420-405-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET141
76420-405-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET201
76420-405-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET281
76420-405-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET301

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 10 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
unii: F05Q2T2JA0
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
unii: F05Q2T2JA0
Docu LiquidDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.f4ed0721-3be9-4108-a6c9-dbbe115249e92025-07-31WarningsExact identifier
unii: F05Q2T2JA0
Senna-SDOCUSATE SODIUM, SENNOSIDESGranulation Technology, Inc.f36c509e-b93b-4d7f-a18a-41e585369a152025-07-30WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmerican Health Packaging7f25bff3-0e86-4bec-b293-54b68347867f2025-07-23Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSomerset Therapeutics, LLCebb570bb-6e5e-489e-875c-9e7b3a6d716a2025-07-16Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
unii: F05Q2T2JA0
Gencare-Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGPioneer Life Sciences, LLCe60b520a-8c7e-40cd-b829-e4c2d7904f612025-06-30WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGATLANTIC BIOLOGICALS CORP.4c02fcec-6bb7-4497-96c5-0d809209dd172025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
unii: F05Q2T2JA0
Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC65a1cce7-984f-490a-bd68-fea97733a72f2025-06-24WarningsExact identifier
unii: F05Q2T2JA0
3810e86a-b46f-14d1-e063-6394a90a1ae742abfb9e-5108-4642-abfb-45c985df588c2025-06-20Warnings, Adverse reactionsExact identifier
spl id: 3810e86a-b46f-14d1-e063-6394a90a1ae7
spl set id: 42abfb9e-5108-4642-abfb-45c985df588c
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMGolden State Medical Supply, Inc.bd3161fe-23d7-458a-86a4-fb958d9c94d32025-06-06Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
unii: F05Q2T2JA0
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: OJ245FE5EU
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmerican Health Packagingf14b8d07-e73b-4ceb-bd6a-578c961b7c092025-05-16Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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