FDA.reportPublic FDA data

NDC 70518-3454-04 - 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
70518-3454
Requested NDC
70518-3454-04
Package NDCs from labels
70518-3454-0, 70518-3454-1, 70518-3454-2, 70518-3454-3, 70518-3454-4, 70518-3454-04
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim Tablets, USPREMEDYREPACK INC.2026-08-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3454-0Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET611
70518-3454-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1411
70518-3454-2Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET611
70518-3454-3Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2011
70518-3454-4Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3454SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20241023_ce44959b-4bfe-4ba9-9fc2-7f9d4663d542.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 1 of 23 · 443 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
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
unii: F05Q2T2JA0
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
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals Inc.c6171b62-835c-465e-905e-97f70438186e2026-09-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGPreferred Pharmaceuticals, Inc.b25b8a28-5e00-4a20-9ca3-7ed494fc45402026-09-01WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMATLANTIC BIOLOGICALS CORP.acc3df02-1e99-46e6-8a31-9b26261c6daa2026-08-25Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc4982b9c6-ed0e-24da-e063-6394a90a147f2026-08-24WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ccec364a-3135-4a5d-b4b0-86b832387b4e2026-08-24WarningsExact identifier
unii: F05Q2T2JA0
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.a1591da0-a1a9-9583-3cf5-788b8fee38142026-08-24Exact identifier
unii: F05Q2T2JA0
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc49837b2c-492f-2fed-e063-6294a90aaa242026-08-21WarningsExact identifier
unii: F05Q2T2JA0
Senokot-SSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.c24cdc5e-62e0-41a6-8afb-512202a569f42026-08-21WarningsExact identifier
unii: F05Q2T2JA0
Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool SoftenerDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGStrategic Sourcing Services LLC5966ff80-7be2-788a-e063-6294a90ab4f32026-08-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.ae2c7300-f9c4-43b5-9f8e-30f2e7d176352026-08-19WarningsExact identifier
unii: F05Q2T2JA0
CVS Stool Softener Fruit PunchDOCUSATE SODIUMCVS PHARMACY, INC0e6900d6-7dc9-47d6-a006-1695feb8d5a52026-08-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)306fd12b-ed60-40dc-a5be-2dc394bd29d22026-08-17WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ce44959b-4bfe-4ba9-9fc2-7f9d4663d5422026-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (package): 70518-3454-4
ndc (package): 70518-3454-3
ndc (package): 70518-3454-0
ndc (package): 70518-3454-2
ndc (package): 70518-3454-1
ndc (product): 70518-3454
ndc11 (package): 70518345404
rxcui: 198334
spl id: 58b2a687-23a6-9c3b-e063-6294a90afa50
spl set id: ce44959b-4bfe-4ba9-9fc2-7f9d4663d542
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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