FDA.reportPublic FDA data

Desonide

Product NDC
51672-4079
11-digit product format
516724079
Labeler code
51672
Product ID
51672-4079_c5e77dd5-c1ab-4967-8000-48077b8e06f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA202161
Marketing category
ANDA
Marketing start
2014-10-31
Substance
DESONIDE
Active strength
.5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ280872D1O
Rxcui197572

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4079-4Desonide59 mL in 1 BOTTLELOTION594
51672-4079-4Desonide1 in 1 CARTONLOTION14
51672-4079-8Desonide1 in 1 CARTONLOTION14
51672-4079-8Desonide118 mL in 1 BOTTLELOTION1184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4079-4ML - Milliliter51672-4079b9ca2853-3e1c-44ba-9c3b-ce4da58d07a812014-12-01
51672-4079-8ML - Milliliter51672-4079c137a6e2-0aac-47b0-877a-a30bde92eb6a12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesonideACTIVE INGREDIENTJ280872D1ODESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
DesonideACTIVE MOIETYJ280872D1ODESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
light mineral oilINACTIVE INGREDIENTN6K5787QVPDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RDESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4079DESONIDE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20210413_af607c32-3da9-4fbe-99e7-4934a5c8d8f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197572desonide 0.05 % Topical LotionPSNaf607c32-3da9-4fbe-99e7-4934a5c8d8f04
197572desonide 0.5 MG/ML Topical LotionSCDaf607c32-3da9-4fbe-99e7-4934a5c8d8f04
197572desonide 0.05 % Topical LotionSYaf607c32-3da9-4fbe-99e7-4934a5c8d8f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4079-4516724079041 BOTTLE in 1 CARTON (51672-4079-4) / 59 mL in 1 BOTTLE1 bottle2014-10-310000-00-00NoNoCurrent
51672-4079-8516724079081 BOTTLE in 1 CARTON (51672-4079-8) / 118 mL in 1 BOTTLE1 bottle2014-10-310000-00-00NoNoCurrent