FDA.reportPublic FDA data

NDC 51672-1364-06 - ADAPALENE 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
51672-1364
Requested NDC
51672-1364-06
Package NDCs from labels
51672-1364-6, 51672-1364-3, 51672-1364-06
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOCUSATE SODIUM - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1364-3ADAPALENE and BENZOYL PEROXIDE45 g in 1 BOTTLE, PUMPGEL454
51672-1364-3ADAPALENE and BENZOYL PEROXIDE1 in 1 CARTONGEL14
51672-1364-6ADAPALENE and BENZOYL PEROXIDE45 g in 1 TUBEGEL454
51672-1364-6ADAPALENE and BENZOYL PEROXIDE1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1364ADAPALENE AND BENZOYL PEROXIDE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 4 package rows20250406_a53f1aa5-d3d1-45af-8728-8f36090f49da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1364-3GM - Gram51672-1364c0970340-d0da-436f-87d7-427d0d62514e12018-02-20

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 8 of 58 · 1,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Clearasil Rapid Rescue Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCcae9204d-4b6f-4fc7-9857-3050ffd6d2fa2026-05-13WarningsExact identifier
unii: W9WZN9A0GM
Clearasil Stubborn Acne Control 5in1 Spot TreatmentBENZOYL PEROXIDEReckitt Benckiser LLCbdb87e60-67a6-4c0e-b0ab-3e238a08269c2026-05-13WarningsExact identifier
unii: W9WZN9A0GM
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticalscc8d1556-f108-4166-837c-48f81152877e2026-05-12WarningsExact identifier
unii: F05Q2T2JA0
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Docusate SodiumDOCUSATE SODIUMForreal Pharmaceuticals, LLC118dccb7-5df2-432d-b7d3-37b3f1ade0aa2026-05-07WarningsExact identifier
unii: F05Q2T2JA0
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact identifier
unii: F05Q2T2JA0
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
unii: F05Q2T2JA0
Zapzyt Acne Treatment GelBENZOYL PEROXIDEFocus Consumer Healthcare, LLC6079d45c-dd86-6f2e-e053-2991aa0a97432026-04-29WarningsExact identifier
unii: W9WZN9A0GM
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
unii: F05Q2T2JA0
PanOxyl Acne Clearing Spot TreatmentBENZOYL PEROXIDECrown Laboratories507150a0-9c20-4a2e-e063-6394a90ab9c72026-04-27WarningsExact identifier
unii: W9WZN9A0GM
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
unii: F05Q2T2JA0
Tobcharm Acne Treatment Cleansing BarACNE TREATMENT CLEANSING BARGuangzhou Jingliang Cosmetics Co., Ltd.50185cc9-0b3e-64b3-e063-6394a90a0bec2026-04-22WarningsExact identifier
unii: W9WZN9A0GM
Pure Eyes Sterile EyesNAPHAZOLINE HYDROCHLORIDE AND GLYCERINSAMSON PHARMACEUTICALc0234e82-211f-4731-ac48-12db13b16e8a2026-04-21WarningsExact identifier
unii: PDC6A3C0OX
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESWalgreenscd668027-fb64-4e7d-86a5-2f0261599ae92026-04-17WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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