FDA.reportPublic FDA data

NDC 67046-1477-03 - Dapsone

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
67046-1477
Requested NDC
67046-1477-03
Package NDCs from labels
67046-1477-3, 67046-1477-03
Manufacturer
Coupler LLC
Effective date
2025-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dapsone - Coupler LLCCoupler LLC2025-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1477-3Dapsone30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1477DAPSONE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250201_2d018cbb-21b2-5f63-e063-6394a90aadc3.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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapsoneDAPSONEMacleods Pharmaceuticals Limited839d7440-ba0e-4c56-b648-d374b155cf032026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 197557
rxcui: 197558
unii: 8W5C518302
DAPSONEDAPSONEAlembic Pharmaceuticals Limited0f1301f6-884d-4fc7-a5b2-421b2375b9852026-07-09Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DAPSONEDAPSONEAlembic Pharmaceuticals Inc.7249f655-1d8e-482a-889a-1e7e1a19500c2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Dapsone 25mgDAPSONE 25MGSolis Pharmaceuticals Inc.50204029-4c29-5b8d-e063-6394a90af3832026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 197557
rxcui: 197558
unii: 8W5C518302
DapsoneDAPSONESun Pharmaceutical Industries, Inc.cb312185-b9f1-4fa4-9481-bcf5d9bb3edf2026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 197557
rxcui: 197558
unii: 8W5C518302
DapsoneDAPSONEViona Pharmaceuticals Inc58e7b363-99fb-4225-8df1-db2114d749282026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 197557
rxcui: 197558
unii: 8W5C518302
DapsoneDAPSONEZydus Lifesciences Limited1d6bc112-ba2f-40ab-975d-9cfbc853cd112026-02-27Exact identifier
rxcui: 197557
rxcui: 197558
unii: 8W5C518302
DapsoneDAPSONERising Pharma Holdings, Inc.e369b26d-219a-4e23-b8d4-f94048d36acd2026-01-28Warnings, Adverse reactionsExact identifier
application number: ANDA207165
ndc (product): 64980-566
rxcui: 197557
rxcui: 197558
spl id: e1aaf1ed-de8a-4c31-85de-68d728c95e86
spl set id: e369b26d-219a-4e23-b8d4-f94048d36acd
unii: 8W5C518302
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
DapsoneDAPSONEAvKARE13002250-b4c5-5890-e063-6394a90a20362026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 197558
unii: 8W5C518302
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
DapsoneDAPSONEAvKARE459c00e0-2124-8965-e063-6294a90a42782025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 197558
unii: 8W5C518302
DapsoneDAPSONE GEL, 5%Encube Ethicals, Inc.4205a1a9-c459-47bb-9538-1dd559ca71f12025-10-31Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
AczoneDAPSONEAlmirall, LLC22058b7d-a578-4eaa-a476-ac982337f02a2025-10-23Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONEAlembic Pharmaceuticals Limitedd71eba65-3d78-4252-acb8-90eea60921d12025-09-25Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONE GEL, 5%Trupharma, LLC699b6157-3245-43b6-91ee-c86ea262bc832025-09-05Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
DapsoneDAPSONETrupharma, LLC2763bcbb-e249-be2b-e063-6394a90a50152025-09-05Warnings, Adverse reactionsExact identifier
unii: 8W5C518302
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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