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 22 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPbefcc5b0-04bb-4211-b3dd-88f400c7fa782023-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
SODIUM PHENYLACETATE AND SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALS, INC3529be10-0004-4628-9ca1-67a8acd86b512023-07-05Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
TrimethoprimTRIMETHOPRIMGolden State Medical Supply, Inc.f756f4be-3cda-ab98-e053-6294a90a14242023-03-20Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsd8239804-d234-491b-965d-89a7796a5e4d2023-02-04Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sodium Phenylacetate and Sodium BenzoateSODIUM PHENYLACETATE AND SODIUM BENZOATEMAIA PHARMACEUTICALSab40b62b-9f8d-4394-92d5-09d9f1941eaa2023-01-16Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMDenton Pharma, Inc. DBA Northwind Pharmaceuticalsa12bf393-d8ef-48df-e053-2a95a90a1af12023-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ede74118-32c5-4f52-9823-509538e674c82022-10-09Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPc407381f-3d8e-4fdf-9132-cd39680992962022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
TrimethoprimTRIMETHOPRIMNovitium Pharma LLC95a1572c-6109-4d1f-bf92-262015a7654e2022-08-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
AddiclenzBETA VULGARIS, BOLDO, 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, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP29e83667-8d4a-49b7-9182-653cbfb2dee72022-05-02Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAsclemed USA, Inc.e6c0f80a-ba22-4690-aaf8-48a4602b68312020-09-04Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVista Pharmaceuticals, Inc.3edca473-8fdc-462a-b378-6c3279503a702020-01-22Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP0df74ba1-1aa6-467c-92e7-6b017c7c6bce2019-11-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
STOOL SOFTENING SENNA LAXATIVESENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MGTARGET CORPORATION7c74bd91-6687-2b89-e053-2a91aa0ad6b82019-02-28WarningsExact identifier
unii: F05Q2T2JA0
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU

Reported adverse events (FAERS/openFDA)#

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