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 19 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
unii: F05Q2T2JA0
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
unii: F05Q2T2JA0
Docu LiquidDOCUSATE SODIUMATLANTIC BIOLOGICALS CORP.f4ed0721-3be9-4108-a6c9-dbbe115249e92025-07-31WarningsExact identifier
unii: F05Q2T2JA0
Senna-SDOCUSATE SODIUM, SENNOSIDESGranulation Technology, Inc.f36c509e-b93b-4d7f-a18a-41e585369a152025-07-30WarningsExact identifier
unii: F05Q2T2JA0
ONEXTONCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC697e760a-c206-4565-8f4e-a8085e2158272025-07-23Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Cleocin PhosphateCLINDAMYCIN PHOSPHATEProPharma Distribution38416189-844b-939f-e063-6394a90aa2712025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Clindamycin PhosphateCLINDAMYCIN PHOSPHATENORTHSTAR RX LLCf8c7339a-5180-4c6a-99bf-8a7e4d94f2d22025-07-09Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
unii: W9WZN9A0GM
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN AND BENZOYL PEROXIDE GELSun Pharmaceutical Industries, Inc.bde03712-b9c7-4953-af2e-d3270ba1a9172025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 358917
rxcui: 308694
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN AND BENZOYL PEROXIDE GELSun Pharmaceutical Industries, Inc.10e10bc2-4074-4268-916b-dd2f40fb7bb32025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 358917
rxcui: 308694
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN AND BENZOYL PEROXIDE GELSun Pharmaceutical Industries, Inc.3b151c49-d44c-4a24-b7ff-329797a2cda32025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 358917
rxcui: 308694
ADAPALENE and BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.a53f1aa5-d3d1-45af-8728-8f36090f49da2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.b39aaacb-f429-4cb4-b88b-341b8b8b217c2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.0a98fc1e-be75-4c22-a7a7-2e4f033b37012025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Clindamycin PhosphateCLINDAMYCIN PHOSPHATESun Pharmaceutical Industries, Inc.20333796-e2b9-4e11-860b-1dc5ff038b032025-07-03Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.449884c1-cf3b-4e2c-b8a0-82442ea8523a2025-07-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Adapalene and Benzoyl PeroxideADAPALENE AND BENZOYL PEROXIDESun Pharmaceutical Industries, Inc.13fc72e9-7178-4a8b-9fe8-d88ba591dac82025-07-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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