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 16 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
CleocinCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLCf9be442d-0782-4b93-828f-9ebbf67dbced2025-11-19Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEA-S Medication Solutionsba3f54e5-1ff5-4ffd-8ed2-f15439f423e92025-11-18Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLCa7fa9a4b-0fa3-4003-bfb1-8f26ca7109892025-11-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
unii: F05Q2T2JA0
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
unii: F05Q2T2JA0
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Naturium Benzoyl Peroxide Cleanser 5%BENZOYL PEROXIDEe.l.f. Cosmetics, Inc0a278590-e98b-7cab-e063-6394a90a4d0e2025-11-07WarningsExact identifier
unii: W9WZN9A0GM
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy1ed3a4d3-629c-4d70-ac03-d0db9f77a9c82025-11-06WarningsExact identifier
unii: F05Q2T2JA0
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories54ebb0ba-e32c-4b8e-8427-b947ca6441502025-11-03WarningsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories42e9bea8-e840-4163-929e-967baf5f2f902025-11-03WarningsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories1ac05b1f-d508-4e9b-bef1-22e522ad740f2025-11-03WarningsExact identifier
unii: W9WZN9A0GM
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDERugby Laboratories5af89ec6-0f4a-451a-8a45-5194115dc8282025-11-03WarningsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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