NDC 68791-101

Derma-Smoothe/FS

Fluocinolone Acetonide

Derma-Smoothe/FS is a Topical Oil in the Human Prescription Drug category. It is labeled and distributed by Royal Pharmaceuticals. The primary component is Fluocinolone Acetonide.

Product ID68791-101_3df7816c-9330-4fff-9b75-4b7deb565b54
NDC68791-101
Product TypeHuman Prescription Drug
Proprietary NameDerma-Smoothe/FS
Generic NameFluocinolone Acetonide
Dosage FormOil
Route of AdministrationTOPICAL
Marketing Start Date1995-02-16
Marketing CategoryNDA / NDA
Application NumberNDA019452
Labeler NameRoyal Pharmaceuticals
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68791-101-04

1 BOTTLE in 1 CARTON (68791-101-04) > 118.28 mL in 1 BOTTLE
Marketing Start Date1995-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68791-101-04 [68791010104]

Derma-Smoothe/FS OIL
Marketing CategoryNDA
Application NumberNDA019452
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-02-16

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

OpenFDA Data

SPL SET ID:bc61c619-a71c-46f5-80f1-9e9ee71134aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191309
  • 1191307

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    Medicade Reported Pricing

    68791010104 DERMA-SMOOTHE-FS BODY OIL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Derma-Smoothe/FS" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    68791-102Derma-Smoothe/FSDerma-Smoothe/FS
    68791-101Derma-Smoothe/FSDerma-Smoothe/FS
    0299-5500Capexfluocinolone acetonide
    39328-079Flac Otic Oilfluocinolone acetonide
    0168-0058Fluocinolone Acetonidefluocinolone acetonide
    0168-0059Fluocinolone Acetonidefluocinolone acetonide
    0168-0060Fluocinolone Acetonidefluocinolone acetonide
    0168-0064Fluocinolone Acetonidefluocinolone acetonide
    0713-0223Fluocinolone AcetonideFluocinolone Acetonide
    0713-0224Fluocinolone AcetonideFluocinolone Acetonide
    0713-0324Fluocinolone AcetonideFluocinolone Acetonide
    0713-0325Fluocinolone AcetonideFluocinolone Acetonide
    0713-0709FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    10135-670fluocinolone acetonidefluocinolone acetonide
    13925-506Fluocinolone Acetonidefluocinolone acetonide
    13925-507Fluocinolone Acetonidefluocinolone acetonide
    42291-283Fluocinolone AcetonideFluocinolone Acetonide
    42291-284Fluocinolone AcetonideFluocinolone Acetonide
    42291-285Fluocinolone AcetonideFluocinolone Acetonide
    43386-069Fluocinolone AcetonideFluocinolone Acetonide
    13925-508Fluocinolone acetonide 0.01%fluocinolone acetonide
    24208-416RetisertFluocinolone Acetonide
    43538-900Synalarfluocinolone acetonide
    43538-901SynalarFluocinolone acetonide
    43538-910Synalarfluocinolone acetonide
    43538-911SynalarFluocinolone acetonide
    43538-920Synalarfluocinolone acetonide
    43538-921Synalar TSfluocinolone acetonide

    Trademark Results [Derma-Smoothe/FS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DERMA-SMOOTHE/FS
    DERMA-SMOOTHE/FS
    75057572 2213615 Live/Registered
    HILL DERMACEUTICALS, INC.
    1996-02-13
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