FDA.reportPublic FDA data

Clobetasol Propionate (emollient)

Product NDC
72162-2628
11-digit product format
721622628
Labeler code
72162
Product ID
72162-2628_99405b91-475b-4174-a989-9954e763d2df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA209411
Marketing category
ANDA
Marketing start
2025-09-29
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate (emollient)
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui1992281

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
72162-2628-2Clobetasol Propionate (emollient)1 in 1 CARTONCREAM1100
72162-2628-2Clobetasol Propionate (emollient)15 g in 1 TUBECREAM15100
72162-2628-3Clobetasol Propionate (emollient)30 g in 1 TUBECREAM30100
72162-2628-3Clobetasol Propionate (emollient)1 in 1 CARTONCREAM1100
72162-2628-6Clobetasol Propionate (emollient)60 g in 1 TUBECREAM60100
72162-2628-6Clobetasol Propionate (emollient)1 in 1 CARTONCREAM1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2628-2GM - Gram72162-2628facfbb0d-1ac0-4d5b-8fe6-afddd6dc830012026-05-22
72162-2628-3GM - Gram72162-2628a0924398-4cbf-4687-ab3c-bd8bb6601b9f12026-05-22
72162-2628-6GM - Gram72162-26284e7781d0-ef23-4002-8155-96f4dee451db12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamPSNcb0bc057-d6ab-4eea-af7a-01661ae9b517100
1992281Emollient clobetasol propionate 0.5 MG/ML Topical CreamSCDcb0bc057-d6ab-4eea-af7a-01661ae9b517100
1992281clobetasol propionate 0.05 % Emollient Base Topical CreamSYcb0bc057-d6ab-4eea-af7a-01661ae9b517100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2628-2721622628021 TUBE in 1 CARTON (72162-2628-2) / 15 g in 1 TUBE1 tube2026-04-23NoNoHistorical
72162-2628-3721622628031 TUBE in 1 CARTON (72162-2628-3) / 30 g in 1 TUBE1 tube2026-04-23NoNoHistorical
72162-2628-6721622628061 TUBE in 1 CARTON (72162-2628-6) / 60 g in 1 TUBE1 tube2026-04-23NoNoHistorical