FDA.reportPublic FDA data

Derma-Smoothe/FS

Product NDC
68791-101
11-digit product format
687910101
Labeler code
68791
Product ID
68791-101_a1decdf5-a06c-40b9-a2b4-d27006b8f01c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
TOPICAL
Labeler
Royal Pharmaceuticals
Application
NDA019452
Marketing category
NDA
Marketing start
1995-02-16
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Derma-Smoothe/FS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68791-101-042024-02-12C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Body Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Body Oil. DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988
68791-101-042024-02-12C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Body Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Body Oil. DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988
68791-101-042024-02-12C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Derma-Smoothe/FS ® safely and effectively. See full prescribing information for Derma-Smoothe/FS ® . Derma-Smoothe/FS ® (fluocinolone acetonide) Topical Oil, 0.01% (Body Oil) For Topical Use Only Not for Oral, Ophthalmic, or Intravaginal Use NDC 68791-101-04 Initial U.S. Approval: 1988
68791-101-042024-01-30C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Body Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Body Oil. DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988
68791-101-042024-01-30C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Body Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Body Oil. DERMA-SMOOTHE/FS Body Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988
68791-101-042024-01-30C16284748780-11030e365-64aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Derma-Smoothe/FS ® safely and effectively. See full prescribing information for Derma-Smoothe/FS ® . Derma-Smoothe/FS ® (fluocinolone acetonide) Topical Oil, 0.01% (Body Oil) For Topical Use Only Not for Oral, Ophthalmic, or Intravaginal Use NDC 68791-101-04 Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68791-101-01Derma-Smoothe/FS1 in 1 CARTONOIL113
68791-101-01Derma-Smoothe/FS20 mL in 1 BOTTLEOIL2013
68791-101-04Derma-Smoothe/FS118.28 mL in 1 BOTTLEOIL118.2813
68791-101-04Derma-Smoothe/FS1 in 1 CARTONOIL113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68791-101-04ML - Milliliter68791-1014dd95654-736e-4f93-bd66-7bde032de4d112013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
OLETH-2INACTIVE INGREDIENT7L6R1SQ6M0DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68791-101DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS]12Current NDC, Legacy NDC, 4 package rows20250426_bc61c619-a71c-46f5-80f1-9e9ee71134aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68791-101-01687910101011 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE1 bottle2024-05-062026-06-30YesNoHistorical
68791-101-04687910101041 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE1 bottle1995-02-160000-00-00NoNoCurrent