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 9 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb7c0-3c08-02cd-e063-6294a90a67492026-04-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd4f0bb38a-765b-d072-e063-6294a90a8d4d2026-04-09WarningsExact identifier
application number: M006
ageLOC LumiSpa Treatment Cleanser AcneSALICYLIC ACIDNSE Products, Inc7f478ae8-8b97-4cdf-a023-cea14b992ff92026-04-03WarningsExact identifier
application number: M006
Anew Bare Acne Clearing Treatment 2% Salicylic AcidSALICYLIC ACIDTHE AVON COMPANY4e7d1429-0498-5812-e063-6394a90a4d4d2026-04-02WarningsExact identifier
application number: M006
UNBLEMISH 30-Day RegimenSALICYLIC ACID, BENZOYL PEROXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fieldse9a52ccc-6ba0-4417-86cc-b2116a5b8d262026-04-01WarningsExact identifier
application number: M006
ageLOC LumiSpa Blemish SerumSALICYLIC ACIDNSE Products, Inc.35cdc16c-9a51-4ee9-b39d-36f29c4176ae2026-04-01WarningsExact identifier
application number: M006
UNBLEMISH Refining Acne WashSALICYLIC ACIDRodan & Fields08922efa-5a90-4dfb-b9f4-a6c4f8dba3c92026-03-31WarningsExact identifier
application number: M006
purity made simpleSALICYLIC ACIDPhilosophy, Inc.ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb2026-03-31WarningsExact identifier
application number: M006
UNBLEMISH Dual Intensive Acne TreatmentBENZOYL PEROXIDERodan & Fields27ea743c-e080-487d-adc5-e31176f5b9fc2026-03-30WarningsExact identifier
application number: M006
SPESOLSKII MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEBEST GREEN LIMITED4e35f848-2e9c-d0c6-e063-6294a90a8d4b2026-03-29WarningsExact identifier
application number: M006
Purito Acne Intensive TreatmentSALICYLIC ACIDHinature Inc.ca5ab57f-ddcb-4ced-8dd3-a698ad2d17de2026-03-26WarningsExact identifier
application number: M006
Oxy Vitamin C SerumSALICYLIC ACID 0.5%The Mentholatum Company2a34ceef-d442-1c2d-e063-6294a90a66392026-03-25WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cream CleanserBENZOYL PEROXIDE 5%The Mentholatum Company288da995-eda8-5d1c-e063-6394a90a38b22026-03-25WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dde8b03-84e2-5ec7-e063-6394a90a69102026-03-25WarningsExact identifier
application number: M006
Rael Beauty Miracle Clear Complete Acne SerumSALICYLIC ACIDRael, Inc.fdb7ecd2-c4c8-90b6-e053-6294a90a69b12026-03-25WarningsExact identifier
application number: M006
JTOPYRTSALICYLIC ACID PADGuangzhou Yixiang Trading Co., Ltd.3dfb8f94-f734-de7d-e063-6394a90abed82026-03-25WarningsExact identifier
application number: M006
Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e2026-03-24WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dcc9f0a-24d0-d62e-e063-6394a90aafe22026-03-24WarningsExact identifier
application number: M006
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
application number: M006
Flobow FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4d6fb8af-5641-4a9a-e063-6294a90abfa92026-03-20WarningsExact 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