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 21 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adapalene and benzoyl peroxideADAPALENE AND BENZOYL PEROXIDETeva Pharmaceuticals, Inc.05babd5f-18ab-4646-8962-cb000ed0f9a82022-05-01Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
d955ac6a-ec2e-a197-e053-2a95a90a4f41cfe90535-5b3a-4dc9-e053-2995a90ace3b2022-03-03WarningsExact identifier
spl set id: cfe90535-5b3a-4dc9-e053-2995a90ace3b
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AcanyaCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBausch Health US, LLC3dcd2c96-72b1-4a9f-b65c-08198d63b7df2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Clindamycin Phosphate and Benzoyl PeroxideCLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEOceanside Pharmaceuticalsedae294f-cc8b-4f94-8d90-4c764fda307b2020-09-30Warnings, Adverse reactionsExact identifier
unii: W9WZN9A0GM
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
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
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
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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