FDA.reportPublic FDA data

NDC 52187-554-01 - 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
52187-554
Requested NDC
52187-554-01
Package NDCs from labels
52187-554-01, 52187-554-60
Manufacturer
KMM Pharmaceuticals, LLC
Effective date
2021-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENZOYL PEROXIDE - KMM Pharmaceuticals, LLCKMM Pharmaceuticals, LLC2021-11-03HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-554-01EA - Each52187-5546369f1b0-d13e-469e-8178-bd5a202bb83612022-01-06
52187-554-60EA - Each52187-554737334ee-7570-48d5-917e-54bdf839276112022-01-06

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 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clindamycin phosphate and benzoyl peroxideCLINDAMYCIN, BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd1c7040f2-e503-408a-b07e-72c7972ce78d2023-07-26Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEBryant Ranch Prepackac7f5c47-a06a-495f-a914-13c930106c8d2023-07-17Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltde50e3ef9-3a9b-4172-a908-71c973a7fb5c2023-02-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEZydus Pharmaceuticals USA Inc.83d52507-99a1-4461-b067-5ec01dc6c5d32022-10-05Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE, BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd221de6a3-c1d7-4dcf-a47b-51edaa682c2a2022-10-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDEMayne Pharma Inc.56541736-c70e-4fcd-9614-6cfdc50441362022-08-31Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADAPALENE AND BENZOYL PEROXIDEADAPALENE AND BENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd92dcba02-f42f-482d-8cd5-2b5ab8fa540a2022-06-02Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T

Reported adverse events (FAERS/openFDA)#

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