clobetasol propionate

Product NDC
45802-637
11-digit product format
458020637
Labeler code
45802
Product ID
45802-637_7572ca02-83f9-4f88-b7a1-715eb5e1c56f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA201402
Marketing category
ANDA
Marketing start
2013-02-01
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
A201402-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201402-001AB2

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-143f01610625f2…
2019-09-15 20:21 UTC2019-09A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB2RS2012-08-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201402-001CLOBETASOL PROPIONATE0.05%AEROSOL, FOAM / TOPICALAB22012-08-14cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201402-001AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201402-001AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201402-001AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201402-001AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201402-001AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201402-001AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201402-001AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201402-001AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201402-001AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201402-001AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201402-001AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201402-001AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201402-001AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201402-001AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201402-001AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201402-001AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201402-001AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201402-001AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201402-001AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201402-001AB21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201402-001AB2187673890dc5c…
2021-03-12 10:30 UTC2021-03A201402-001AB215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201402-001AB218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201402-001AB21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201402-001AB213f01610625f2…
2019-09-15 20:21 UTC2019-09A201402-001AB21b00525d2431f…
2019-07-19 19:46 UTC2019-07A201402-001AB21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201402-001AB216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201402-001AB211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201402-001AB21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201402-001AB21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201402-001AB219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201402-001AB21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201402-001AB213f0d92c62455…
2023-05-13 08:27 UTC2023-05A201402-001AB21053a50430f4f…
2023-01-26 05:58 UTC2023-01A201402-001AB213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201402-001AB213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201402-001AB21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201402-001AB21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201402-001AB21cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
clobetasol propionate
Brand name suffix
emollient formulation
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
1992273Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5264dfb8-3f6f-4f20-958d-9b5855806dc8Available 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
45802-637-32clobetasol propionateemollient formulation50 g in 1 CANAEROSOL, FOAM508
45802-637-32clobetasol propionateemollient formulation1 in 1 CARTONAEROSOL, FOAM18
45802-637-33clobetasol propionateemollient formulation1 in 1 CARTONAEROSOL, FOAM18
45802-637-33clobetasol propionateemollient formulation100 g in 1 CANAEROSOL, FOAM1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-637-32GM - Gram45802-63716fdcca3-5dbf-4523-9b3b-231cd160a33212013-02-13
45802-637-33GM - Gram45802-637d0241906-f2ee-491e-9536-1005e8666ab312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOBETASOL PROPIONATEACTIVE INGREDIENT779619577MCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
CLOBETASOLACTIVE MOIETYADN79D536HCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4
WATERINACTIVE INGREDIENT059QF0KO0RCLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PERRIGO NEW YORK INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-637CLOBETASOL PROPIONATE EMOLLIENT FORMULATION (CLOBETASOL PROPIONATE) AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 4 package rows20240823_5264dfb8-3f6f-4f20-958d-9b5855806dc8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tovet (emollient formulation)CLOBETASOL PROPIONATEMedimetriks Pharmaceuticals, Inc.4d5c5b14-9e4f-4d43-a336-e4ae71d34e422024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201402
application number: ANDA201402
clobetasol propionate emollient formulationCLOBETASOL PROPIONATEPadagis Israel Pharmaceuticals Ltd5264dfb8-3f6f-4f20-958d-9b5855806dc82022-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201402
application number: ANDA201402
ndc (product): 45802-637

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992273clobetasol propionate 0.05 % Emollient Base Topical FoamPSN5264dfb8-3f6f-4f20-958d-9b5855806dc88
1992273Emollient clobetasol propionate 0.5 MG/ML Topical FoamSCD5264dfb8-3f6f-4f20-958d-9b5855806dc88
1992273clobetasol propionate 0.05 % Emollient Base Topical FoamSY5264dfb8-3f6f-4f20-958d-9b5855806dc88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-637-32458020637321 CAN in 1 CARTON (45802-637-32) / 50 g in 1 CAN1 can2013-02-010000-00-00NoNoCurrent
45802-637-33458020637331 CAN in 1 CARTON (45802-637-33) / 100 g in 1 CAN1 can2013-02-010000-00-00NoNoCurrent