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 20 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGPioneer Life Sciences, LLCe60b520a-8c7e-40cd-b829-e4c2d7904f612025-06-30WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGATLANTIC BIOLOGICALS CORP.4c02fcec-6bb7-4497-96c5-0d809209dd172025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
unii: F05Q2T2JA0
Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC65a1cce7-984f-490a-bd68-fea97733a72f2025-06-24WarningsExact identifier
unii: F05Q2T2JA0
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEZydus Lifesciences Limitedd374a9b9-3ee9-4bc4-bcb9-a947d76cb6e52025-06-13Exact identifier
unii: W9WZN9A0GM
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEViona Pharmaceuticals Inc3a0fa489-4720-4760-a476-2317aef5a2312025-06-13Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
unii: F05Q2T2JA0
Neutrogena Stubborn Acne AM TreatmentBENZOYL PEROXIDEKenvue Brands LLCd6e05b11-8c5f-490d-a5d8-116dcc895cb82025-06-04WarningsExact identifier
unii: W9WZN9A0GM
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDE TOPICALAlembic Pharmaceuticals Limited2d4e5111-4f9f-42dd-8cf7-56bdc51fbbad2025-05-27Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
unii: F05Q2T2JA0
TWYNEOTRETINOIN AND BENZOYL PEROXIDEGalderma Laboratories, L.P.27208dff-e376-4c18-b56e-0a260f685a392025-05-22Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDE TOPICALAlembic Pharmaceuticals Inc.73a32997-23da-46b6-8652-7197f55c98472025-05-21Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Neutrogena On-the-Spot Acne Treatment Vanishing FormulaBENZOYL PEROXIDEKenvue Brands LLC7cc8f53d-b8e3-4711-a1d3-fd43be35af512025-05-12WarningsExact identifier
unii: W9WZN9A0GM
COLACE EXTRA STRENGTH STOOL SOFTNERDOCUSATE SODIUMAtlantis Consumer Healthcare Inc.34e06b05-64a5-4b3e-af38-cdcd7c1d521b2025-05-01WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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