FDA.reportPublic FDA data

NDC 42292-028-01 - 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
42292-028
Requested NDC
42292-028-01
Package NDCs from labels
42292-028-01, 42292-028-08
Manufacturer
Mylan Institutional Inc.
Effective date
2019-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim Tablets, USPMylan Institutional Inc.2019-11-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-028-01EA - Each42292-02882d7d58a-f7df-454e-8242-7401b034520012016-12-07
42292-028-08EA - Each42292-02882c38478-2a7a-47f8-9fc7-c8b627d74c2212016-12-07

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 12 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES AND DOCUSATE SODIUMMeijer, Inc.2619be6e-877b-16a2-e063-6394a90a68da2025-03-24WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESMeijer, Inc.261a88d6-87d2-7544-e063-6294a90a2e942025-03-24WarningsExact identifier
unii: F05Q2T2JA0
CVS Health Stool Softener Plus stimulant laxative SoftgelDOCUSATE SODIUM, SENNOSIDESCVS Pharmacy, Inc2881d83d-9929-677a-e063-6394a90a04242025-03-19WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limited284b5dac-2b8d-46bf-95fe-80ce03fa178a2025-03-12Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (product): 65862-420
rxcui: 198334
rxcui: 198335
spl id: e4ea8e99-58d4-4c1b-b84c-db0838610059
spl set id: 284b5dac-2b8d-46bf-95fe-80ce03fa178a
unii: AN164J8Y0X
unii: JE42381TNV
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharmac62086ea-ba15-40f5-8431-4639c60c98252025-03-06Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8c74ea5c-d05e-4fc1-b980-aacaab56d4722025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions20054147-811c-471a-8ec4-1b2903fe906e2025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc2025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals of New York LLC3233c54d-484d-4550-b172-db8af47d1b7f2025-02-26Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Se-Natal 19.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE AND DOCUSATE SODIUMSeton Pharmaceuticals635104e6-6a53-4684-ac9a-7ac31b33083d2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F05Q2T2JA0
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Stool Softener and Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESH-E-Bc19280c2-f968-b582-e053-2995a90a9bd32025-02-14WarningsExact identifier
unii: F05Q2T2JA0
STOOL SOFTENER-STIMULANT LAXATIVESTOOL SOFTENER-STIMULANT LAXATIVEKroger Companya22c9f95-e3a9-bfd3-e053-2995a90a3c662025-02-13WarningsExact identifier
unii: F05Q2T2JA0
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
unii: F05Q2T2JA0
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
unii: F05Q2T2JA0
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
unii: F05Q2T2JA0
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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