Controlling Cream

Product NDC
35192-017
11-digit product format
351920017
Labeler code
35192
Product ID
35192-017_ef582a84-c1f0-3291-e053-2995a90afdd6
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CA-BOTANA INTERNATIONAL
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-09
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
1 mg/29.6mg
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NICONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
CINNAMONINACTIVE INGREDIENT5S29HWU6QBCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
CINNAMON LEAF OILINACTIVE INGREDIENTS92U8SQ71VCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
MILLETINACTIVE INGREDIENTTJR6B3R47PCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
OENOTHERA BIENNISINACTIVE INGREDIENT76UI55V071CONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
ROSA CANINA LEAFINACTIVE INGREDIENTJ3N2Z889QPCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9CONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RCONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-017CONTROLLING CREAM (BENZOYL PEROXIDE) CREAM [CA-BOTANA INTERNATIONAL]13Legacy NDC20241211_6f4d2f35-1124-4d3f-b2a4-fca222c67149.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35192-017-053519200170529.6 mg in 1 TUBE (35192-017-05) 29.6 mg2017-11-020000-00-00NoNoCurrent