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 23 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DOCUSATE SODIUMDOCUSATE SODIUMSafecor Health, LLCefe4bf81-fb99-4755-aa23-4f8df5973be82025-01-08WarningsExact identifier
unii: F05Q2T2JA0
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5%Bryant Ranch Prepack049ea4d9-c60e-4406-b199-da5abe92eced2025-01-08Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
unii: W9WZN9A0GM
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGNCS HealthCare of KY, LLC dba Vangard Labsc049ef78-cc16-4209-b553-60cead5c9a802025-01-03WarningsExact identifier
unii: F05Q2T2JA0
Clindamycin PhosphateCLINDAMYCIN PHOSPHATESolaris Pharma Corporationb46941a9-e75f-48f7-b426-03f3074997132025-01-02Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Clindamycin Phosphate and TretinoinCLINDAMYCIN PHOSPHATE AND TRETINOINSolaris Pharma Corporationc3ad6c2d-d106-464d-8e27-67ae94793e882025-01-02Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Laxative Docusate Sodium with SennaDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCcf9075d8-e20e-419a-b996-9b12f49f05f22025-01-01WarningsExact identifier
unii: F05Q2T2JA0
CLENZIDERM THERAPEUTICBENZOYL PEROXIDEObagi Cosmeceuticals LLCf0ad29b6-38b0-4118-a711-3c668ac801ec2025-01-01WarningsExact identifier
unii: W9WZN9A0GM
Vegetable Laxative and Stool SoftnerDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCe84d693d-0041-4c11-8f6a-b5c332f79af92025-01-01WarningsExact identifier
unii: F05Q2T2JA0
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
unii: F05Q2T2JA0
Monat Acne TreatmentBENZOYL PEROXIDEMonat Global Corpf76eb53e-643d-52cf-e053-6394a90a6e8f2024-12-20WarningsExact identifier
unii: W9WZN9A0GM
Dermaharmony 10% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7083b69-fed4-d497-e053-2a95a90a1a8c2024-12-20WarningsExact identifier
unii: W9WZN9A0GM
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
unii: W9WZN9A0GM
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
unii: F05Q2T2JA0
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGRUGBY LABORATORIES2e758ff1-3083-4245-8f58-1c47b042bfdd2024-12-19WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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