Clobex

Product NDC
0299-3848
11-digit product format
002993848
Labeler code
0299
Product ID
0299-3848_a9ce2f1a-7cba-4759-ac1d-7638cf99c7be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA021535
Marketing category
NDA
Marketing start
2003-08-01
Substance
CLOBETASOL PROPIONATE
Active strength
.05 g/100mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-3848-02Clobex1 in 1 CARTONLOTION115
0299-3848-02Clobex59 mL in 1 BOTTLELOTION5915
0299-3848-04Clobex118 mL in 1 BOTTLELOTION11815
0299-3848-04Clobex1 in 1 CARTONLOTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-3848-02ML - Milliliter0299-38480de38a25-2a05-4f79-8951-d0f660a4d22112012-07-24
0299-3848-04ML - Milliliter0299-3848bc8d512d-fe75-49d2-b037-a5a77af9fae812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clobetasol PropionateACTIVE INGREDIENT779619577MCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
ClobetasolACTIVE MOIETYADN79D536HCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
CARBOMER 1342INACTIVE INGREDIENT809Y72KV36CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
Mineral OilINACTIVE INGREDIENTT5L8T28FGPCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
PEG-6 ISOSTEARATEINACTIVE INGREDIENT0E2639OTJYCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
WaterINACTIVE INGREDIENT059QF0KO0RCLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]13
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CLOBETASOLACTIVE MOIETYADN79D536HCLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER 1342INACTIVE INGREDIENT809Y72KV36CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOBEX (CLOBETASOL PROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-3848CLOBEX (CLOBETASOL PROPIONATE) LOTION [GALDERMA LABORATORIES, L.P.]14Current NDC, Legacy NDC, 4 package rows20180212_54eca64c-af43-48ba-bf86-bab9d8e46bb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861505clobetasol propionate 0.05 % Topical LotionPSN54eca64c-af43-48ba-bf86-bab9d8e46bb615
861506Clobex 0.05 % Topical LotionPSN54eca64c-af43-48ba-bf86-bab9d8e46bb615
861506clobetasol propionate 0.5 MG/ML Topical Lotion [Clobex]SBD54eca64c-af43-48ba-bf86-bab9d8e46bb615
861505clobetasol propionate 0.5 MG/ML Topical LotionSCD54eca64c-af43-48ba-bf86-bab9d8e46bb615
861505clobetasol propionate 0.05 % Topical LotionSY54eca64c-af43-48ba-bf86-bab9d8e46bb615
861506Clobex (clobetasol propionate 0.5 MG/ML) Topical LotionSY54eca64c-af43-48ba-bf86-bab9d8e46bb615
861506Clobex 0.05 % Topical LotionSY54eca64c-af43-48ba-bf86-bab9d8e46bb615
861505clobetasol propionate 0.05 % Topical LotionPSNa086ead1-b906-4198-af19-5423957c9e2a1
861506Clobex 0.05 % Topical LotionPSNa086ead1-b906-4198-af19-5423957c9e2a1
861506clobetasol propionate 0.5 MG/ML Topical Lotion [Clobex]SBDa086ead1-b906-4198-af19-5423957c9e2a1
861505clobetasol propionate 0.5 MG/ML Topical LotionSCDa086ead1-b906-4198-af19-5423957c9e2a1
861505clobetasol propionate 0.05 % Topical LotionSYa086ead1-b906-4198-af19-5423957c9e2a1
861506Clobex (clobetasol propionate 0.5 MG/ML) Topical LotionSYa086ead1-b906-4198-af19-5423957c9e2a1
861506Clobex 0.05 % Topical LotionSYa086ead1-b906-4198-af19-5423957c9e2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-3848-02002993848021 BOTTLE in 1 CARTON (0299-3848-02) / 59 mL in 1 BOTTLE1 bottle2003-08-010000-00-00NoNoCurrent
0299-3848-04002993848041 BOTTLE in 1 CARTON (0299-3848-04) / 118 mL in 1 BOTTLE1 bottle2003-08-010000-00-00NoNoCurrent