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 33 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.c0898583-4bbb-41d5-9e84-00cca823024f2024-05-15WarningsExact identifier
unii: F05Q2T2JA0
Walgreens Creamy Acne Face Wash Acne MedicationBENZOYL PEROXIDEWalgreen Company13e5396b-839b-4c08-a98f-f0a36c9a0bff2024-05-09WarningsExact identifier
unii: W9WZN9A0GM
Senna SDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9c986ca8-d540-49c1-b092-94c1bf837c072024-05-09WarningsExact identifier
unii: F05Q2T2JA0
Clindamycin Phoaphate Topical USP, 1%CLINDAMYCIN PHOSPHATE TOPICAL USP, 1%A-S Medication Solutions19363055-9ae7-4f0f-979d-93d0ee2c803f2024-05-06Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
unii: F05Q2T2JA0
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
unii: F05Q2T2JA0
Walgreens Daily Acne Cleanser- Sensitive Skin FormulaBENZOYL PEROXIDEWalgreen Companyacae5006-e647-4f00-b93a-2c0bceee14cb2024-05-01WarningsExact identifier
unii: W9WZN9A0GM
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDECLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBryant Ranch Prepackabede379-52d1-4000-ae38-cc99f88fe3b22024-04-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
unii: F05Q2T2JA0
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
unii: W9WZN9A0GM
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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