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#

RxNav current and historical NDC rows page 1 of 1 · 9 matching rows.

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

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
Derma-Smoothe/FSFLUOCINOLONE ACETONIDERoyal Pharmaceuticals, LLCbc61c619-a71c-46f5-80f1-9e9ee71134aa2026-06-09Warnings, Adverse reactionsExact identifier
ndc (package): 68791-101-04
ndc (package): 68791-101-01
ndc (product): 68791-101
ndc11 (package): 68791010104
ndc11 (package): 68791010101
rxcui: 1191309
DERMA-SMOOTHE/FSFLUOCINOLONE ACETONIDERoyal Pharmaceuticals113e167a-a9fe-440e-9446-d6d87963ef462026-06-09Warnings, Adverse reactionsExact identifier
ndc (package): 68791-102-01
ndc (package): 68791-102-04
ndc (product): 68791-102
ndc11 (package): 68791010201
ndc11 (package): 68791010204
rxcui: 1191309

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
3dd5a2f2-d8ff-48d8-a83e-1d44ee68325bNational Council for Prescription Drug Programs20120724
6a302cd2-fba9-48c3-af42-6cfedb9071dcNational Council for Prescription Drug Programs20120724
ab88b426-b9e8-47d5-8df6-b0a4e00dee13National Council for Prescription Drug Programs20120724
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