FDA.reportPublic FDA data

Oxy 5

Product NDC
10742-8356
11-digit product format
107428356
Labeler code
10742
Product ID
10742-8356_2979a2c2-fae9-ac85-e063-6294a90a3dc5
Type
HUMAN OTC DRUG
Nonproprietary name
benzoyl peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-01
Substance
BENZOYL PEROXIDE
Active strength
50 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxy 5
Brand name suffix
Tinted
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/g

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
106309Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
94c863f0-711a-4807-ba1f-a56c7e3f8670Available 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
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
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8356-12023-02-07C16284748780-1f386c64a-40e1-0266-e053-dadaa90a7c1aDrug Facts - Oxy 5 Tinted
10742-8356-12023-01-30C16284748780-1f386c64a-40e1-0266-e053-dadaa90a7c1aDrug Facts - Oxy 5 Tinted

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8356-1Oxy 5Tinted30 g in 1 BOTTLELOTION303
10742-8356-1Oxy 5Tinted1 in 1 CARTONLOTION13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4OXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0OXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0ROXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8356OXY 5 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]3Current NDC, Legacy NDC, 2 package rows20241219_94c863f0-711a-4807-ba1f-a56c7e3f8670.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 55 · 1,096 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58e901b8-66e0-d2d6-e063-6394a90ae6012026-08-13WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-08-13WarningsExact identifier
application number: M006
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsExact identifier
application number: M006
WART REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD58d245c3-c685-5784-e063-6294a90a1e232026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.66e0a0a5-22b5-4c89-a949-e996071a585b2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.13b5a729-e265-47fd-b082-2557805d08bc2026-08-12WarningsExact identifier
application number: M006
24 PK BLEMISH DOTSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.9339d7ed-6e8a-48d2-a5dd-76d395e8d2652026-08-12WarningsExact identifier
application number: M006
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
application number: M006
CLERIVY MICRODART ACNESALICYLIC ACIDGuhada Co., Ltd.555e0963-025e-3731-e063-6394a90a679d2026-08-11WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEMalezia LLCb1304464-bd7e-fb5d-e053-2995a90a54c42026-08-11WarningsExact identifier
application number: M006
SUZANOBAGIMD Acne Cleansing WipesSALICYLIC ACIDObagi Cosmeceuticals LLC91517c5a-1653-41f3-8dfb-a9dea620765c2026-08-10WarningsExact identifier
application number: M006
APUREE Prorevive Maximum Strength AntifungalCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.58860baa-070a-7b73-e063-6294a90acdf02026-08-08WarningsExact identifier
application number: M006
DG Health Athletes FootTOLNAFTATEDolgencorp, LLC42eb14a8-d5e0-42e1-a5a2-3f65bbfa6f3f2026-08-07WarningsExact identifier
application number: M006
Acne Control CleanserSALICYLIC ACIDCVS Health07cb1c7c-5188-49d5-916e-e2161b5ca3b02026-08-06WarningsExact identifier
application number: M006
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106309benzoyl peroxide 5 % Topical LotionPSN94c863f0-711a-4807-ba1f-a56c7e3f86703
106309benzoyl peroxide 50 MG/ML Topical LotionSCD94c863f0-711a-4807-ba1f-a56c7e3f86703
106309benzoyl peroxide 5 % Topical LotionSY94c863f0-711a-4807-ba1f-a56c7e3f86703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8356-1107428356011 BOTTLE in 1 CARTON (10742-8356-1) / 30 g in 1 BOTTLE1 bottle2015-07-010000-00-00NoNoCurrent