FDA.reportPublic FDA data

NDC 45802-998 - 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
45802-998
Package NDCs from labels
45802-998-03
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
45802-998-03clindamycin and benzoyl peroxide27.6 g in 1 BOTTLE, PUMPGEL27.6 g50 mg in 1g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-998CLINDAMYCIN AND BENZOYL PEROXIDE KIT [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Unmatched20231011_6bf0f3e5-6ad7-4791-9483-0977b18ad77f.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 42 of 43 · 844 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
unii: F05Q2T2JA0
AcanyaCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC3dcd2c96-72b1-4a9f-b65c-08198d63b7df2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticalsedae294f-cc8b-4f94-8d90-4c764fda307b2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
unii: EH6D7113I8
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
unii: F05Q2T2JA0
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate 1.2% and Tretinoin 0.025%CLINDAMYCIN PHOSPHATE AND TRETINOINOceanside Pharmaceuticals63b2e85d-8fe5-4f18-9e85-8492c49a75202020-04-01Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
ClindagelCLINDAMYCINBausch Health US, LLCf7b4e985-719a-4547-b624-94612d5209912020-01-01Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
unii: W9WZN9A0GM
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
unii: W9WZN9A0GM
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
unii: W9WZN9A0GM
STOOL SOFTENING SENNA LAXATIVESENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MGTARGET CORPORATION7c74bd91-6687-2b89-e053-2a91aa0ad6b82019-02-28WarningsExact identifier
unii: F05Q2T2JA0
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
SkinPharmacy Advanced Acne Therapy Spot TreatmentBENZOYL PEROXIDECVS Healthefb570f0-8edc-4d8d-a62e-7d824a52b2f72017-03-28WarningsExact identifier
unii: W9WZN9A0GM

Reported adverse events (FAERS/openFDA)#

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