FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
42254-153
11-digit product format
422540153
Labeler code
42254
Product ID
42254-153_b6b530b3-5218-4838-adee-08e477757b98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA074220
Marketing category
ANDA
Marketing start
2010-06-07
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-153IInactivated by FDA2026-07-31
excluded packagepackage42254-15342254-153-15IInactivated by FDA2026-07-31
excluded packagepackage42254-15342254-153-30IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074220-001CORMAXCLOBETASOL PROPIONATE0.05%CREAM / TOPICAL1997-05-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074220-001CORMAX0.05%CREAM / TOPICAL1997-05-16a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-153-152019-09-24C16284748780-19350213a-3d94-c013-e053-90daa90a1393Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
42254-153-302019-09-24C16284748780-19350213a-3d94-c013-e053-90daa90a1393Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-153-15Clobetasol Propionate1 in 1 CARTONCREAM11
42254-153-15Clobetasol Propionate15 g in 1 TUBECREAM151
42254-153-30Clobetasol Propionate30 g in 1 TUBECREAM301
42254-153-30Clobetasol Propionate1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-153-15GM - Gram42254-153a5e8980f-66cb-4b79-b3c8-67abef3a5b9312012-07-24
42254-153-30GM - Gram42254-15309ec83a8-041e-4c6f-bc15-47fee6ac8c4b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
LANOLININACTIVE INGREDIENT7EV65EAW6HCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ECLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-153CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20120420_b6b530b3-5218-4838-adee-08e477757b98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSNb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.05 % Topical OintmentPSNb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCDb6b530b3-5218-4838-adee-08e477757b981
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDb6b530b3-5218-4838-adee-08e477757b981
861495clobetasol propionate 0.05 % Topical CreamSYb6b530b3-5218-4838-adee-08e477757b981
861448clobetasol propionate 0.05 % Topical OintmentSYb6b530b3-5218-4838-adee-08e477757b981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-153-15422540153151 in 1 CARTONHistorical
42254-153-304225401533030 g in 1 TUBE30 gHistorical