FDA.reportPublic FDA data

Cetaphil Gentle Clear BPO Acne Cleanser

Product NDC
0299-4125
11-digit product format
002994125
Labeler code
0299
Product ID
0299-4125_b20c8c1a-9311-4ad9-a713-fa3451dc6f7e
Type
HUMAN OTC DRUG
Nonproprietary name
benzoyl peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
BENZOYL PEROXIDE
Active strength
2.6 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cetaphil Gentle Clear BPO Acne Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE2.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1655910Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6397f20f-d69f-47e4-a123-4cc7e1abfcadAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4125-00Cetaphil Gentle Clear BPO Acne Cleanser124 mL in 1 TUBECREAM1243
0299-4125-05Cetaphil Gentle Clear BPO Acne Cleanser12 mL in 1 TUBECREAM123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4125CETAPHIL GENTLE CLEAR BPO ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [GALDERMA LABORATORIES, L.P.]3Current NDC, Legacy NDC, 2 package rows20231201_6397f20f-d69f-47e4-a123-4cc7e1abfcad.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 16 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv Renewing CleanserBENZOYL PEROXIDEAlchemee, LLC85c22f3a-b6c5-44a2-959c-532c6456ec302026-01-07WarningsExact identifier
application number: M006
Proactiv Repairing TreatmentBENZOYL PEROXIDEAlchemee, LLC9bbf6db0-ff80-44d2-b81b-40080ca46b922026-01-07WarningsExact identifier
application number: M006
Proactiv Deep Cleansing WashSALICYLIC ACIDTHE PROACTIV COMPANY LLC4a2bd12d-f166-43cf-b175-d20affc805262026-01-07WarningsExact identifier
application number: M006
Proactiv Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
application number: M006
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
application number: M006
Proactiv Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
application number: M006
Proactivplus Skin Smoothing ExfoliatorBENZOYL PEROXIDEAlchemee, LLCb56b63d6-5635-4fd4-9517-8b08c3cbf9aa2026-01-07WarningsExact identifier
application number: M006
Proactivplus Smoothing BHA CleanserSALICYLIC ACIDAlchemee, LLC14b9a54c-9993-385e-e063-6394a90a27de2026-01-07WarningsExact identifier
application number: M006
Proactiv Blemish Control Body CreamSALICYLIC ACIDAlchemee, LLC164d2c7f-5f1e-d0a8-e063-6294a90a95f22026-01-07WarningsExact identifier
application number: M006
Proactiv Redness Correcting TreatmentSALICYLIC ACIDAlchemee, LLC25ca582d-158f-2c97-e063-6394a90a56582026-01-07WarningsExact identifier
application number: M006
Proactiv Acne Clearing BodySALICYLIC ACIDAlchemee, LLC22559e3a-3ca4-fb38-e063-6394a90ada9e2026-01-07WarningsExact identifier
application number: M006
Proactiv MD KitMD KITAlchemee, LLC1d142dba-145c-fb33-e063-6394a90a88b62026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Beginner BundleCLEAN KITAlchemee, LLC201e1b5e-555a-92c0-e063-6394a90a13602026-01-07WarningsExact identifier
application number: M006
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
application number: M006
Proactiv Solution KitSOLUTIONS KITAlchemee, LLC17f359a0-04a2-d112-e063-6394a90a27352026-01-07WarningsExact identifier
application number: M006
Universal Clarifying PadSALICYLIC ACIDAllure Labs47d3c57c-d6d2-a9e0-e063-6294a90a3b5b2026-01-07WarningsExact identifier
application number: M006
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
application number: M006
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
application number: M006
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655910benzoyl peroxide 2.6 % Medicated Liquid SoapPSN6397f20f-d69f-47e4-a123-4cc7e1abfcad3
1655910benzoyl peroxide 26 MG/ML Medicated Liquid SoapSCD6397f20f-d69f-47e4-a123-4cc7e1abfcad3
1655910benzoyl peroxide 2.6 % Medicated Liquid SoapSY6397f20f-d69f-47e4-a123-4cc7e1abfcad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-4125-0000299412500124 mL in 1 TUBE (0299-4125-00) 124 ml2022-05-010000-00-00NoNoCurrent
0299-4125-050029941250512 mL in 1 TUBE (0299-4125-05) 12 ml2022-05-010000-00-00NoNoCurrent