DesOwen

Product NDC
0299-5765
11-digit product format
002995765
Labeler code
0299
Product ID
0299-5765_5d3f519a-8957-4b8e-8525-88799e299f2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
ANDA072354
Marketing category
ANDA
Marketing start
1988-07-15
Marketing end
0000-00-00
Substance
DESONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5765-02ML - Milliliter0299-576562ac5a5a-e552-4378-8074-5634ab17694812012-07-24
0299-5765-04ML - Milliliter0299-57654e3752c1-d82b-4153-b616-e9437860d90512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesonideACTIVE INGREDIENTJ280872D1ODESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
DesonideACTIVE MOIETYJ280872D1ODESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Cetyl alcoholINACTIVE INGREDIENT936JST6JCNDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Edetate sodiumINACTIVE INGREDIENTMP1J8420LUDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Propyl gallateINACTIVE INGREDIENT8D4SNN7V92DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Sorbic AcidINACTIVE INGREDIENTX045WJ989BDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
Stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6
WaterINACTIVE INGREDIENT059QF0KO0RDESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5765DESOWEN (DESONIDE) CREAM DESOWEN (DESONIDE) LOTION [GALDERMA LABORATORIES, L.P.]7Legacy NDC20190206_a7e5f030-b849-4805-94e6-f45631eaa37f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5765-020029957650259 g in 1 BOTTLE (0299-5765-02) 59 g1988-07-150000-00-00NoNoCurrent
0299-5765-04002995765041 BOTTLE in 1 CARTON (0299-5765-04) > 118 g in 1 BOTTLE1 bottle1988-07-150000-00-00NoNoCurrent