FDA.reportPublic FDA data

fluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]

RxCUI
1191309
RxNorm name
fluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]
Display name
DERMA-SMOOTHE FS (Topical)
Full name
fluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]
Term type
SBD
Status
Active
Strength
0.01%
Dose form
Oil
Route
Topical
Updated
2026-07-18 07:00:10

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
fluocinolone acetonide0.1 MG / 1 MLfluocinolonefluocinolone acetonide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Oil316984

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
fluocinolone25126

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRDerma-Smoothe/FS 0.01 % Topical OilNAMES
RxNorm Namefluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]NAMES
RxNorm SynonymDerma-Smoothe/FS 0.01 % Topical OilNAMES
RxNorm SynonymDerma-Smoothe/FS 0.1 MG/ML Topical OilNAMES
TTYSBDATTRIBUTES
SPL_SET_ID113e167a-a9fe-440e-9446-d6d87963ef46CODES
SPL_SET_IDbc61c619-a71c-46f5-80f1-9e9ee71134aaCODES
RxCUI1191309CODES
MMSL_CODEBD3131CODES
MMSL_CODEBD7067CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
68791-101-0168791-101Derma-Smoothe/FS fluocinolone acetonideRoyal PharmaceuticalsNDA019452
68791-101-0468791-101Derma-Smoothe/FS fluocinolone acetonideRoyal PharmaceuticalsNDA019452
68791-102-0168791-102DERMA-SMOOTHE/FS fluocinolone acetonideRoyal PharmaceuticalsNDA019452
68791-102-0468791-102DERMA-SMOOTHE/FS fluocinolone acetonideRoyal PharmaceuticalsNDA019452

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA01945268791-101Derma-Smoothe/FS fluocinolone acetonideNDARoyal Pharmaceuticals

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
68791010101rxnav_ndcsyes
68791010104rxnav_ndcsyes
68791010201rxnav_ndcsyes
68791010204rxnav_ndcsyes
28105014904rxnav_historical
28105015004rxnav_historical
54868157200rxnav_historical
54868535100rxnav_historical
60433014904rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
113e167a-a9fe-440e-9446-d6d87963ef46Derma-Smoothe/FS Scalp 0.01 % Topical OilPSN15These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 198820250701
113e167a-a9fe-440e-9446-d6d87963ef46Derma-Smoothe/FS 0.1 MG/ML Topical OilSY15These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 198820250701
113e167a-a9fe-440e-9446-d6d87963ef46fluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]SBD15These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 198820250701
113e167a-a9fe-440e-9446-d6d87963ef46Derma-Smoothe/FS 0.01 % Topical OilSY15These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 198820250701
8943d103-353e-463a-93e5-3b2a977b6061Derma-Smoothe/FS Scalp 0.01 % Topical OilPSN1Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)20120601
8943d103-353e-463a-93e5-3b2a977b6061Derma-Smoothe/FS 0.01 % Topical OilSY1Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)20120601
8943d103-353e-463a-93e5-3b2a977b6061fluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]SBD1Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)20120601
8943d103-353e-463a-93e5-3b2a977b6061Derma-Smoothe/FS 0.1 MG/ML Topical OilSY1Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)20120601

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
113e167a-a9fe-440e-9446-d6d87963ef46These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988Royal Pharmaceuticals20260609
bc61c619-a71c-46f5-80f1-9e9ee71134aaThese 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: 1988Royal Pharmaceuticals, LLC | HILL DERMACEUTICALS, INC.20260609
113e167a-a9fe-440e-9446-d6d87963ef46These highlights do not include all the information needed to use DERMA-SMOOTHE/FS Scalp Oil safely and effectively. See full prescribing information for DERMA-SMOOTHE/FS Scalp Oil. DERMA-SMOOTHE/FS Scalp Oil (fluocinolone acetonide) topical oil Initial U.S. Approval: 1988Royal Pharmaceuticals20250701
bc61c619-a71c-46f5-80f1-9e9ee71134aaThese 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: 1988Royal Pharmaceuticals20250630
bc61c619-a71c-46f5-80f1-9e9ee71134aaThese 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: 1988Royal Pharmaceuticals, LLC | HILL DERMACEUTICALS, INC.20240831
8943d103-353e-463a-93e5-3b2a977b6061Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)Physicians Total Care, Inc.20120601

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS02BACorticosteroidsATC1-4fluocinolone acetonide
ATCC05AACorticosteroidsATC1-4fluocinolone acetonide
ATCS01BACorticosteroids, plainATC1-4fluocinolone acetonide
ATCD07ACCorticosteroids, potent (group III)ATC1-4fluocinolone acetonide
FDASPLN0000175576CorticosteroidEPChas_epcfluocinolone acetonide
FDASPLN0000175450Corticosteroid Hormone Receptor AgonistsMOAhas_moafluocinolone acetonide
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone
MEDRTD005446Fluocinolone AcetonideCHEMhas_ingredientfluocinolone acetonide
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatfluocinolone acetonide
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone
MEDRTD004342Drug HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone
MEDRTD005148Facial DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone
MEDRTD005533Foot DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone
MEDRTD006229Hand DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD006967HypersensitivityDISEASEci_withfluocinolone acetonide
MEDRTD007249InflammationDISEASEmay_treatfluocinolone
MEDRTD007249InflammationDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTD007868Leg DermatosesDISEASEmay_treatfluocinolone
MEDRTD011537PruritusDISEASEmay_treatfluocinolone
MEDRTD011537PruritusDISEASEmay_treatfluocinolone acetonide
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone acetonide
MEDRTD011565PsoriasisDISEASEmay_treatfluocinolone
MEDRTD012536Scalp DermatosesDISEASEmay_treatfluocinolone acetonide
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moafluocinolone acetonide
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone acetonide
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moafluocinolone
MEDRTN0000008297Antipruritic ActivityPEhas_pefluocinolone acetonide
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone acetonide
MEDRTN0000008663Decreased Immunologically Active Molecule ActivityPEhas_pefluocinolone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pefluocinolone acetonide
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone acetonide
MEDRTN0000009908VasoconstrictionPEhas_pefluocinolone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3131
CODESMMSL_CODEBD7067
CODESNDANDA019452
CODESRxCUI1191309
CODESSPL_SET_ID113e167a-a9fe-440e-9446-d6d87963ef46
CODESSPL_SET_IDbc61c619-a71c-46f5-80f1-9e9ee71134aa
NAMESPrescribable SynonymDerma-Smoothe/FS Scalp 0.01 % Topical Oil
NAMESRXNAV_STRDerma-Smoothe/FS 0.01 % Topical Oil
NAMESRxNorm Namefluocinolone acetonide 0.1 MG/ML Topical Oil [Derma-Smoothe FS]
NAMESRxNorm SynonymDerma-Smoothe/FS 0.01 % Topical Oil
NAMESRxNorm SynonymDerma-Smoothe/FS 0.1 MG/ML Topical Oil
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon