FDA.reportPublic FDA data

Clobetasol Propionate (emollient)

Product NDC
0168-0301
11-digit product format
001680301
Labeler code
0168
Product ID
0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA075430
Marketing category
ANDA
Marketing start
1999-05-26
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A075430-001CLOBETASOL PROPIONATE (EMOLLIENT)CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2RS1999-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075430-001AB2

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 22:54:322026-06A075430-001CLOBETASOL PROPIONATE (EMOLLIENT)0.05%CREAM / TOPICALAB2RS1999-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075430-001AB21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol Propionate (emollient)CLOBETASOL PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.fdfd83ee-dfb4-4c12-a74e-a0053e34e08c2021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075430
application number: ANDA075430
ndc (product): 0168-0301

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate (emollient)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
779619577MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1992281Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdfd83ee-dfb4-4c12-a74e-a0053e34e08cAvailable on FDA.report

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
0168-0301-152020-09-16C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-302020-09-16C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-602020-09-16C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-152020-07-22C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-302020-07-22C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994
0168-0301-602020-07-22C16284748780-1ab0e2407-27d0-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0301-15Clobetasol Propionate (emollient)1 in 1 CARTONCREAM110
0168-0301-15Clobetasol Propionate (emollient)15 g in 1 TUBECREAM1510
0168-0301-30Clobetasol Propionate (emollient)30 g in 1 TUBECREAM3010
0168-0301-30Clobetasol Propionate (emollient)1 in 1 CARTONCREAM110
0168-0301-60Clobetasol Propionate (emollient)60 g in 1 TUBECREAM6010
0168-0301-60Clobetasol Propionate (emollient)1 in 1 CARTONCREAM110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0301-15GM - Gram0168-03012970c874-5a51-4e83-ada8-09c3b7d8d18d12012-07-24
0168-0301-30GM - Gram0168-03018a5648af-fe50-42bb-96ea-e6d3f858614f12012-07-24
0168-0301-60GM - Gram0168-03017ddbef40-e047-4dff-b94a-4f6dfbfa50bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clobetasol propionateACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
clobetasolACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
ceteth-20INACTIVE INGREDIENTI835H2IHHXCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
imidureaINACTIVE INGREDIENTM629807ATLCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
waterINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0301CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 6 package rows20220112_fdfd83ee-dfb4-4c12-a74e-a0053e34e08c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSNfdfd83ee-dfb4-4c12-a74e-a0053e34e08c10
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCDfdfd83ee-dfb4-4c12-a74e-a0053e34e08c10
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSYfdfd83ee-dfb4-4c12-a74e-a0053e34e08c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0301-15001680301151 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE1 tube1999-05-260000-00-00NoNoCurrent
0168-0301-30001680301301 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE1 tube1999-05-260000-00-00NoNoCurrent
0168-0301-60001680301601 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE1 tube1999-05-260000-00-00NoNoCurrent