FDA.reportPublic FDA data

NDC 0904-2725-60 - 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
0904-2725
Requested NDC
0904-2725-60
Package NDCs from labels
0904-2725-61, 0904-2725-60
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim - Cardinal Health 107, LLCCardinal Health 107, LLC2026-08-07HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole and Trimethoprim - Major PharmaceuticalsMajor Pharmaceuticals2025-11-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2725-61Sulfamethoxazole and Trimethoprim100 in 1 CARTONTABLET10018
0904-2725-61Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2725SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]16Current NDC, Legacy NDC, 2 package rows20250214_abe0d2d5-4879-4b4e-9b57-47ea83a17ba0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2725-40EA - Each0904-2725309a6f5a-7a9f-4466-8d83-24e7b1633a3d12012-07-24
0904-2725-60EA - Each0904-272584e4f990-5cb8-4b71-9954-cdbff531d2a112012-07-24
0904-2725-61EA - Each0904-2725a7eef1e1-21bf-43ef-9826-eaedbcd63c2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]8

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 1 of 8 · 160 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEREMEDYREPACK INC.c68818b2-d849-41d2-be07-731244afbbac2026-09-09Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals, Inc.cd4932ce-0856-4e99-8baf-70afce1d7ffd2026-09-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals Inc.d60c218c-6529-4944-af0b-a9dc720f32e92026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals Inc.c6171b62-835c-465e-905e-97f70438186e2026-09-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMATLANTIC BIOLOGICALS CORP.acc3df02-1e99-46e6-8a31-9b26261c6daa2026-08-25Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ce44959b-4bfe-4ba9-9fc2-7f9d4663d5422026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 198334
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC5dc03027-cdaf-461f-87fd-630d382fc7232026-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA076899
ndc (package): 55154-7895-0
ndc (product): 55154-7895
rxcui: 198335
spl id: 20e937b5-67f6-4632-abe4-7031b1d77a17
spl set id: 5dc03027-cdaf-461f-87fd-630d382fc723
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ec2e335c-3357-40d8-9615-a09fc40ce5f42026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.c45ac3a4-d397-486e-abd1-3499165430682026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC08500fcb-dbec-4ac2-91c3-189d27907ec02026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMUnit Dose Solutions, Inc.562e2547-db2d-e2d2-e063-6294a90a1f5d2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSt. Mary's Medical Park Pharmacye3a49508-0ebe-1334-e053-2a95a90ae1732026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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