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

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 1 of 56 · 1,105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
application number: M006
Jack Black Bump FixSALICYLIC ACIDJack Black, L.L.C.e8f51678-2675-405c-8462-351ec260051a2026-09-08WarningsExact identifier
application number: M006
Abib Acne foam cleanser Heartleaf foamSALICYLIC ACIDFourcompany Co., Ltd.5aa353ad-0ca5-77c1-e063-6394a90a62542026-09-04WarningsExact identifier
application number: M006
Dr.Leo Acne Buster Salicylic Acid DryingSALICYLIC ACIDDoctor Leo USA Inc5792fa71-eb6b-3c70-e063-6394a90abde82026-09-03WarningsExact identifier
application number: M006
Blackhead Clearing ScrugSALICYLIC ACIDWalmart Inc.6989591a-a78b-4971-baf2-51ebfaf9c7e72026-09-02Warnings, Adverse reactionsExact identifier
application number: M006
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
application number: M006
Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.5a93f753-eb7d-ad11-e063-6294a90a67782026-09-01WarningsExact identifier
application number: M006
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
application number: M006
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
application number: M006
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
application number: M006
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
application number: M006
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
application number: M006
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
application number: M006
Acne Treatment CreamBENZOYL PEROXIDECVS Healthaef82711-e3c3-439d-adda-542933ff44202026-08-19WarningsExact identifier
application number: M006
Tula Skincare Acne Heroes Acne Clearing KitSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5967255f-b511-9c7f-e063-6294a90a3e632026-08-19WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 2% MILIA REMOVERShenzhen Jindali Technology Co., Ltd596a2471-d07c-14a5-e063-6394a90a4fcc2026-08-19WarningsExact identifier
application number: M006
RFA Clear and Calm Balancing SerumSALICYLIC ACIDTopiderm, Inc.f63f2c89-3567-4b08-be51-3fdfc5e0b1ba2026-08-14WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact 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