United States· US:68791-102_94081df6-a3f4-48f9-b79a-8c123c946db7

DERMA-SMOOTHE/FS

A fluocinolone acetonide product containing fluocinolone acetonide, registered in United States by Royal Pharmaceuticals. The same ATC class is registered in 10 of our 19 countries.

ATC S01BA15Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDERMA-SMOOTHE/FSATCS01BA15REGISTER NO.US:68791-102_94081df6…PACKS LISTED2CHECKEDJune 3, 2026

Where it is registered

Fluocinolone acetonide is registered in 10 of 19 countries.

Countries holding a registration under ATC S01BA15 (fluocinolone acetonide), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 7 of them publish a price we can compare per daily dose

Fluocinolone acetonide · ATC S01BA15

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
fluocinolone acetonide
Manufacturer
Royal Pharmaceuticals
Country
United States (US)
ATC code
S01BA15
ATC class
Fluocinolone acetonide
Defined daily dose
1 DE, IVT
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    6879110201
    1 BOTTLE in 1 CARTON (68791-102-01) / 20 mL in 1 BOTTLE
  • ndc11
    6879110204
    1 BOTTLE in 1 CARTON (68791-102-04) / 118.28 mL in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
N019452
ATATAT
DailyMed SPL labels
1 version tracked

Interactions

10 interactions on record for fluocinolone acetonide.

Graded by severity as the source publishes them — 10 info. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Fluocinolone acetonide · interactions on record

10 records

Interaction register. Grades as the source publishes them.

Same medicine, other countries

Fluocinolone acetonide in 13 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fluocinolone acetonide products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Iluvien
  • Belgium · Iluvien
  • Bulgaria · Абрикорт, Флуцинар
  • Czechia · Flucinar, Iluvien
  • Germany · Flucinar, Iluvien
  • Denmark · Iluvien, Otazem
  • Spain · Ekzem, Fluocid Forte
  • Finland · Iluvien, Otazem
  • France · Iluvien
  • United Kingdom (Northern Ireland) · Iluvien, Synalar
  • Greece · Synalar Simple
  • Hungary · Flucinar
  • Ireland · Iluvien
  • Italy · Ekzem, Fluovitef
  • Lithuania · Flucinar
  • Luxembourg · Iluvien
  • Latvia · Flucinar
  • Netherlands · Iluvien
  • Norway · Iluvien, Otazem
  • Poland · Flucinar, Iluvien
  • Portugal · Ekzem, Iluvien
  • Romania · Fluocinolon Acetonid Laropharm
  • Sweden · Iluvien, Otazem
  • Slovakia · Flucinar

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/53a6f36a-caa4-4f58-a76d-0d64db960ac9
GET /v1/drugs/53a6f36a-caa4-4f58-a76d-0d64db960ac9?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "0CD5FD6S2M",
    "rxcui": "4461",
    "inchikey": "FEBLZLNTKCEFIT-VSXGLTOVSA-N",
    "display_name": "FLUOCINOLONE ACETONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "bc61c619-a71c-46f5-80f1-9e9ee71134aa": {
      "match": "brand_token",
      "title": "DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [ROYAL PHARMACEUTICALS, LLC]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68791-102_94081df6-a3f4-48f9-b79a-8c123c946db7",
  "productndc": "68791-102",
  "dosage_form": "OIL",
  "orange_book": {
    "appl_no": "019452",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Feb 3, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "002",
        "approval_date": "Nov 9, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.01%",
        "product_no": "003",
        "approval_date": "Nov 9, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE",
  "proprietary_name": "DERMA-SMOOTHE/FS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019452",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluocinolone acetonide",
  "start_marketing_date": "19950216",
  "active_numerator_strength": ".11"
}

See everything about fluocinolone acetonide.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.