FDA.reportPublic FDA data

AGE INTERVENTION DUALITY

Product NDC
65113-2372
11-digit product format
651132372
Labeler code
65113
Product ID
65113-2372_698580fb-8dea-4a63-9cbb-3a1df814b407
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
G.S. COSMECEUTICAL USA, INC.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-01
Substance
BENZOYL PEROXIDE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AGE INTERVENTION DUALITY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE10 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui106315

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
65113-2372-22022-01-12C16284748780-1960f7f55-c75e-8e05-e053-dbdaa90a074aAGE INTERVENTION ® DUALITY ™
65113-2372-22019-10-29C16284748780-1960f7f55-c75e-8e05-e053-dbdaa90a074aAGE INTERVENTION ® DUALITY ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-2372-2AGE INTERVENTION DUALITY28 g in 1 BOTTLE, PUMPCREAM284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
CHRYSININACTIVE INGREDIENT3CN01F5ZJ5AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A065AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1RAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
RETINOLINACTIVE INGREDIENTG2SH0XKK91AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-2372AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]4Current NDC, Legacy NDC, 1 package rows20241116_33fb5893-ea63-49a3-bb02-6b98c747c4fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106315benzoyl peroxide 10 % Topical CreamPSN33fb5893-ea63-49a3-bb02-6b98c747c4fe4
106315benzoyl peroxide 100 MG/ML Topical CreamSCD33fb5893-ea63-49a3-bb02-6b98c747c4fe4
106315benzoyl peroxide 10 % Topical CreamSY33fb5893-ea63-49a3-bb02-6b98c747c4fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65113-2372-26511323720228 g in 1 BOTTLE, PUMP (65113-2372-2) 28 g2011-05-010000-00-00NoNoCurrent