FDA.reportPublic FDA data

NDC 45802-997 - clindamycin and benzoyl peroxide

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
45802-997
Package NDCs from labels
45802-997-01
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2022-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
clindamycin and benzoyl peroxide - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2022-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-997-01clindamycin and benzoyl peroxide19.7 g in 1 JARGEL19.7 g50 mg in 1g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-997CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Unmatched20231011_f5e0ce64-605d-487c-a7b9-c00457925d94.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 14 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCfd7560ce-5e52-4ba8-b52c-82500611818a2025-12-18WarningsExact identifier
unii: W9WZN9A0GM
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCfc69294e-80d4-427f-a0f7-70cecda136da2025-12-18WarningsExact identifier
unii: W9WZN9A0GM
BP WashBENZOYL PEROXIDECINTEX SERVICES, LLCe26c5cad-1ae6-48f0-abf4-02a01c79538c2025-12-18WarningsExact identifier
unii: W9WZN9A0GM
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyae9d1672-9ade-4139-9126-5289b87fe5742025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Clindamycin PhosphateCLINDAMYCIN PHOSPHATE TOPICALCarnegie Pharmaceuticals, LLCc8fe61f1-f3c5-4452-9980-a727461b98442025-12-15Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
clindamycin phosphateCLINDAMYCIN PHOSPHATEMylan Pharmaceuticals Inc.f7480256-8b32-419a-8983-e2c413040dba2025-12-12Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
unii: F05Q2T2JA0
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
unii: F05Q2T2JA0
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
unii: F05Q2T2JA0
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
unii: F05Q2T2JA0
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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