Suppliers and packagers for DERMA-SMOOTHE/FS

DERMA-SMOOTHE/FS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hill Dermac	DERMA-SMOOTHE/FS	fluocinolone acetonide	OIL;TOPICAL	019452	NDA	Royal Pharmaceuticals, LLC	68791-101-04	1 BOTTLE in 1 CARTON (68791-101-04) / 118.28 mL in 1 BOTTLE	1995-02-16
Hill Dermac	DERMA-SMOOTHE/FS	fluocinolone acetonide	OIL;TOPICAL	019452	NDA	Royal Pharmaceuticals	68791-102-04	1 BOTTLE in 1 CARTON (68791-102-04) / 118.28 mL in 1 BOTTLE	1995-02-16
Hill Dermac	DERMA-SMOOTHE/FS	fluocinolone acetonide	OIL;TOPICAL	019452	NDA	Royal Pharmaceuticals	68791-103-20	1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER	2005-11-09

Suppliers and packagers for DERMA-SMOOTHE/FS

Last updated: July 8, 2026

Suppliers for DERMA-SMOOTHE/FS (Topical Fluocinolone Acetonide Oil)

DERMA-SMOOTHE/FS is a topical fluocinolone acetonide product sold in the US as a prescription corticosteroid oil (commonly used for inflammatory scalp dermatoses). Suppliers in the US typically map to (1) the active ingredient (fluocinolone acetonide), (2) the finished-dose manufacturer of the drug product, and (3) contract manufacturers that fill/finish and package the oil into the marketed container/kit configuration.

Who manufactures DERMA-SMOOTHE/FS drug product in the US?

Answer: The branded product’s “finished drug product” supply chain is governed by the company listed as the NDA holder and/or the labeled manufacturer/distributor on the US prescribing information and package labeling. Those entities control release, lot disposition, labeling, and regulatory compliance for the marketed oil.

What to look for on DERMA-SMOOTHE/FS labels to identify suppliers

• NDA holder/distributor: entity that appears on the carton bottle label and US prescribing information.
• Manufacturer of record: the site/company credited for manufacturing and packaging on the label.
• Packager/filler: if the label credits separate fill-finish sites, those are the practical “suppliers” for dosing units.
• Private label arrangements: if labeled as “manufactured for” by another firm, that firm is the drug product supplier even when marketing is under the brand.

Common supply-chain roles behind a corticosteroid oil

• API suppliers (fluocinolone acetonide): provide drug substance to formulators.
• Formulation and drug product manufacturers: produce the oil formulation, package into the final container, and perform stability and release testing.
• Contract fill-finish sites: dispense, seal, and label at GMP grade.

Which suppliers provide the active pharmaceutical ingredient (fluocinolone acetonide) for DERMA-SMOOTHE/FS?

Answer: Fluocinolone acetonide is a steroid API with a global sourcing footprint. For DERMA-SMOOTHE/FS, the API supplier is generally the company supplying fluocinolone acetonide to the NDA holder or to the contract drug product manufacturer on contract terms.

How to map API suppliers to the branded product

• Supplier lists are usually not public as “DERMA-SMOOTHE/FS API supplier is X” in US-facing documents.
• Practical mapping uses one of these public anchors:
  • Current GMP inspection records tied to the NDA holder’s supply chain (site-level).
  • US drug master file (DMF) references that may identify API manufacturers (indirect).
  • Quality agreements and supply disclosures referenced in regulatory submissions (rarely public).
• In litigation and compliance workflows, API sourcing is sometimes surfaced via discovery, but that is case-specific.

Are there multiple sourcing contracts for DERMA-SMOOTHE/FS?

Answer: Branded topical products typically use at least dual sourcing options for raw materials and often for drug product manufacturing sites, especially where the product is made under GMP with validated supplier qualification.

What drives multiple suppliers

• Steroid API availability cycles and lead-time risk
• Container closure system supply continuity
• Packaging line capacity
• Stability and change control management across batch sites

How to tell if multiple suppliers exist

• Multiple manufacturing sites listed in label/package insert.
• Lot-level manufacturer codes and National Drug Code (NDC) packaging variations that reflect different plants.
• Public inspection reports for more than one site credited for “manufacturing and packaging.”

What is the supplier landscape for the formulation and fill-finish of fluocinolone oil?

Answer: For steroid oils, the practical supplier landscape usually clusters into:

1. the NDA holder’s internal manufacturing sites or contracted drug product manufacturers, and
2. contract packaging and fill-finish organizations.

Key contract-manufacturing capabilities

• Sterile risk is low for a non-sterile topical oil, but GMP grade oil blending and controlled particle/viscosity specs are critical.
• Controlled stirring and homogeneity qualification.
• Container closure integrity and label application under GMP.
• Stability and photostability management for corticosteroid oils.

Where fill-finish suppliers sit in the chain

• Fill-finish suppliers typically:
  • receive bulk drug product (oil) from the drug product site,
  • fill into bottles/containers,
  • apply tamper evidence and labeling,
  • release final packaged lots to the distribution chain.

Which contract manufacturers supply DERMA-SMOOTHE/FS to wholesalers and pharmacies?

Answer: Contract manufacturers are typically the labeled “manufactured for” or “manufactured by” entities on DERMA-SMOOTHE/FS packaging. Wholesalers do not typically “source” the product beyond distribution agreements; they buy from labeled manufacturer/distributor.

Mapping suppliers via the NDC

• The NDC identifies the specific marketed strength, dosage form, and package configuration.
• Different NDCs can reflect:
  • different pack sizes,
  • different package types,
  • different fill-finish/packaging plants.

How do DERMA-SMOOTHE/FS suppliers differ by geography (US vs. EU vs. other markets)?

Answer: Supplier networks differ by regulatory jurisdiction because each region has its own marketing authorization, local GMP compliance, and release testing requirements.

US-specific realities

• US supply chain is tied to:
  • the FDA NDA holder,
  • US-labeled manufacturing sites,
  • lot release under US GMP,
  • distribution through US wholesalers and specialty pharmacy channels.

What supplier constraints can affect availability of DERMA-SMOOTHE/FS?

Answer: Availability risk for topical steroids is driven by:

• API supply constraints for fluocinolone acetonide
• packaging and container closure constraints
• batch release failures due to viscosity, content uniformity, or stability excursions
• manufacturing site capacity during demand spikes

Key Takeaways

• “Suppliers for DERMA-SMOOTHE/FS” breaks into API sourcing (fluocinolone acetonide) and drug product/fill-finish supply (oil formulation and packaged dosing units).
• In practice, the only reliable public anchor for finished-dose suppliers is the entity listed as NDA holder/distributor and the labeled “manufactured by / manufactured for” parties on package labeling and prescribing information.
• API supplier identities are typically not product-specific in public US materials; mapping requires regulatory-site references, DMF linkages, or discovery from case records.

FAQs

1. How can I identify the drug product manufacturer for DERMA-SMOOTHE/FS from the label?
   Look for “Manufactured by” or “Manufactured for” and the site address printed on the carton/bottle label; align that entity with the NDC.

2. Is the active ingredient in DERMA-SMOOTHE/FS sourced from the same API supplier worldwide?
   Global sourcing can differ by region due to local GMP approvals and contract structures, even if the API is the same molecule.

3. Do DERMA-SMOOTHE/FS packaging changes indicate different fill-finish suppliers?
   Often yes when NDCs change in ways consistent with different packaging configurations or when multiple labeled manufacturing sites exist.

4. What factors most commonly disrupt topical steroid oil supply chains?
   API lead times, packaging container closure system availability, and GMP release/stability issues.

5. How are suppliers typically tied to regulatory filings for DERMA-SMOOTHE/FS?
   Finished-dose suppliers map to the NDA holder and labeled manufacturer of record; API suppliers map indirectly via DMF/QC references and site-level regulatory documentation.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-09).
2. FDA. Drugs@FDA. (Accessed 2026-07-09).