derma-smoothe/fs

Generic: fluocinolone acetonide

Labeler: royal pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name derma-smoothe/fs
Generic Name fluocinolone acetonide
Labeler royal pharmaceuticals
Dosage Form OIL
Routes
TOPICAL
Active Ingredients

fluocinolone acetonide .11 mg/mL

Manufacturer
Royal Pharmaceuticals

Identifiers & Regulatory

Product NDC 68791-101
Product ID 68791-101_a1decdf5-a06c-40b9-a2b4-d27006b8f01c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019452
Listing Expiration 2026-12-31
Marketing Start 1995-02-16

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68791101
Hyphenated Format 68791-101

Supplemental Identifiers

RxCUI
1191307 1191309
UNII
0CD5FD6S2M
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name derma-smoothe/fs (source: ndc)
Generic Name fluocinolone acetonide (source: ndc)
Application Number NDA019452 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .11 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE
source: ndc

Packages (2)

68791-101-01 1 BOTTLE in 1 CARTON (68791-101-01) / 20 mL in 1 BOTTLE 68791-101-04 1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE

Ingredients (1)

fluocinolone acetonide (.11 mg/mL)

Linked Drug Pages (1)

Derma-Smoothe/FS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a1decdf5-a06c-40b9-a2b4-d27006b8f01c", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["0CD5FD6S2M"], "rxcui": ["1191307", "1191309"], "spl_set_id": ["bc61c619-a71c-46f5-80f1-9e9ee71134aa"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Royal Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (68791-101-01)  / 20 mL in 1 BOTTLE", "package_ndc": "68791-101-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68791-101-04)  / 118.28 mL in 1 BOTTLE", "package_ndc": "68791-101-04", "marketing_start_date": "19950216"}], "brand_name": "Derma-Smoothe/FS", "product_id": "68791-101_a1decdf5-a06c-40b9-a2b4-d27006b8f01c", "dosage_form": "OIL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68791-101", "generic_name": "fluocinolone acetonide", "labeler_name": "Royal Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Derma-Smoothe/FS", "active_ingredients": [{"name": "FLUOCINOLONE ACETONIDE", "strength": ".11 mg/mL"}], "application_number": "NDA019452", "marketing_category": "NDA", "marketing_start_date": "19950216", "listing_expiration_date": "20261231"}