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 9 of 43 · 848 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
unii: F05Q2T2JA0
HEALIX SENNA-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGBrainstorm Industries LLC4cc5388f-1716-5d19-e063-6394a90a5a252026-03-11WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMAmerisource Bergen4caf0bcb-c1bf-0ae7-e063-6294a90a344b2026-03-10WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
unii: F05Q2T2JA0
CleocinCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLC3db26227-208d-4fdd-8426-1d9be5cda9b42026-03-09Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreensb03e1500-0a4f-4e3d-a897-d7781fd5f7912026-03-09WarningsExact identifier
unii: F05Q2T2JA0
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUM 100MGPharbest Pharmaceuticals, Inc.025e03e0-e273-47ed-87f7-98e388abe0472026-03-05WarningsExact identifier
unii: F05Q2T2JA0
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack5c08f86e-abd7-4717-b902-74ea336ce28a2026-03-05Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Acne TreatmentBENZOYL PEROXIDEWalmart Inc.950edb4e-fbba-41e3-9ec5-973806e555e72026-02-27Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Acne TreatmentBENZOYL PEROXIDEThe Kroger Co.a6526d73-4094-45b7-97f0-561dd10d61e22026-02-26Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
unii: F05Q2T2JA0
Clindamycin PhosphateCLINDAMYCIN PHOSPHATE GEL USP, 1%Encube Ethicals, Inc.ac21d7ad-f94e-4d57-95e3-1648add7ad0b2026-02-25Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
XACIATOCLINDAMYCIN PHOSPHATEOrganon LLC0423007f-28fa-4159-bf58-9174626d23472026-02-19Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Acne CleanserBENZOYL PEROXIDEMeijer, Inc.932ee049-ab3d-4839-a655-772e5594f6e12026-02-19Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
unii: F05Q2T2JA0
ClindamycinCLINDAMYCIN PHOSPHATEHenry Schein, Inc.8a4e2ba4-90e6-48e8-a943-0c5d3f1697802026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: EH6D7113I8
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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