FDA.reportPublic FDA data

OXY

Product NDC
10742-1202
11-digit product format
107421202
Labeler code
10742
Product ID
10742-1202_292bf757-118a-68b5-e063-6294a90a0aaf
Type
HUMAN OTC DRUG
Nonproprietary name
benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
Substance
BENZOYL PEROXIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXY
Brand name suffix
Advanced Care Soothing Cream Acne Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui142034

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1202-12023-02-07C16284748780-1f386c64a-22e5-0266-e053-dadaa90a7c1aDrug Facts - OXY Advanced Care Soothing Cream Acne Cleanser
10742-1202-22023-02-07C16284748780-1f386c64a-22e5-0266-e053-dadaa90a7c1aDrug Facts - OXY Advanced Care Soothing Cream Acne Cleanser
10742-1202-12023-01-30C16284748780-1f386c64a-22e5-0266-e053-dadaa90a7c1aDrug Facts - OXY Advanced Care Soothing Cream Acne Cleanser
10742-1202-22023-01-30C16284748780-1f386c64a-22e5-0266-e053-dadaa90a7c1aDrug Facts - OXY Advanced Care Soothing Cream Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1202-1OXYAdvanced Care Soothing Cream Acne Cleanser148 mL in 1 TUBEGEL1485
10742-1202-2OXYAdvanced Care Soothing Cream Acne Cleanser185 mL in 1 TUBEGEL1855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1202OXY ADVANCED CARE SOOTHING CREAM ACNE CLEANSER (BENZOYL PEROXIDE) GEL [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 2 package rows20241215_4171b8a9-7ebf-4c02-a086-87038b6c68c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN4171b8a9-7ebf-4c02-a086-87038b6c68c45
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD4171b8a9-7ebf-4c02-a086-87038b6c68c45
142034benzoyl peroxide 10 % Medicated Liquid SoapSY4171b8a9-7ebf-4c02-a086-87038b6c68c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-1202-110742120201148 mL in 1 TUBE (10742-1202-1) 148 ml2021-09-010000-00-00NoNoCurrent
10742-1202-210742120202185 mL in 1 TUBE (10742-1202-2) 185 ml2021-12-010000-00-00NoNoCurrent