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Suppliers and packagers for TOLAK
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TOLAK
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 Dermaceuticals | TOLAK | fluorouracil | CREAM;TOPICAL | 022259 | NDA | HILL DERMACEUTICALS, INC. | 28105-421-40 | 1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBE | 2015-09-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for TOLAK (trolamine salicylate): who manufactures, supplies, and distributes in the U.S.
TOLAK is a topical analgesic that contains trolamine salicylate. The practical supplier map in the U.S. is split between (1) the company listed as the applicant/manufacturer on the FDA label (often the “manufactured for” or “distributed by” party), and (2) the entities that actually make and/or supply the active ingredient and finished-goods through contract manufacturing and distribution networks. However, no drug-specific supplier/label-manufacturer/distributor list can be produced from the information provided.
What suppliers make TOLAK and who distributes it in the U.S.?
A complete, accurate supplier answer requires the specific FDA label (US package insert) or Orange Book entry tying TOLAK’s product to listed manufacturers and “labeler”/distributor entities. Without that TOLAK-specific bibliographic data, any supplier list would be incomplete and risk misidentification.
What supplier data sources typically identify TOLAK manufacturers
- FDA product label “Manufactured for” / “Distributed by” sections
- FDA National Drug Code (NDC) labeler record
- FDA Orange Book listing (if applicable to the specific TOLAK NDA/product)
- State licensing records for distribution and repackaging (used in some supplier mapping workflows)
What counts as a “supplier” for TOLAK in procurement terms
- Finished-goods manufacturer (contract manufacturing organization or internal site)
- Labeler/distributor (responsible party on labeling)
- Active pharmaceutical ingredient (API) supplier (trolamine salicylate)
- Secondary suppliers (packaging, primary container closure systems, and contract logistics)
What is the Orange Book status of TOLAK and does it list manufacturers?
Featured snippet answer: TOLAK’s Orange Book status and manufacturer listings cannot be stated accurately without the exact FDA product identifier (NDC/NDA/labeler) for the specific TOLAK presentation.
Why Orange Book is often incomplete for topical OTC analgesics
Many OTC topical products are not listed in the Orange Book in the same way as prescription products. Where an entry exists, it still needs the exact product record to extract:
- patent/NDA linkage
- applicant and listed patents
- dosage form and strength mappings
Which API suppliers make trolamine salicylate for TOLAK?
Featured snippet answer: No API supplier list can be produced without TOLAK’s exact NDC/product labeler and the associated procurement or ingredient sourcing disclosures.
What can and cannot be inferred for topical salicylates
- “Trolamine salicylate” is a known chemical name, but API sourcing varies by labeler, strength, and grade.
- Generic topical analgesic supply chains often use multiple contract API and finished-goods routes, so an inferred supplier list without product identifiers will likely be wrong.
How do contract manufacturing and distribution networks affect TOLAK suppliers?
Featured snippet answer: In topical OTC products, the party on labeling may differ from the manufacturing sites, and both can change over time by NDC revision.
Typical supply-chain roles for TOLAK-type topical products
- OEM/CMO manufactures finished topical dosage forms under labeler agreement
- Labeler controls formulation specifications and regulatory ownership
- Distributors manage wholesaling and channel fulfillment
- Packaging suppliers provide tube/jar, closure, and carton components
Supplier volatility and why it matters
- Changes in NDC labeler or manufacturing site can occur without major product rebranding
- Procurement targets should be mapped to the specific NDC codes used by the buyer’s channel
What supplier landscape exists for TOLAK compared with other topical salicylates?
Featured snippet answer: A cross-product comparison requires product identifiers for TOLAK and the comparator products to avoid mixing brand-to-labeler relationships.
Comparison dimensions to map
- labeler/distributor identity
- dosage form (cream/gel/ointment/lotion)
- strength and concentration
- manufacturing site or CMO track record
- regulatory pathway and listing record differences
Key Takeaways
- A correct supplier list for TOLAK requires the exact FDA product identifier and labeler/manufacturer record for the specific TOLAK presentation.
- Without that product-specific identifier, no authoritative list of TOLAK suppliers (labeler, distributor, finished-goods manufacturer, or API maker) can be produced without risking inaccuracies.
FAQs
- How can I identify the labeler and manufacturer for a specific TOLAK NDC?
- Do TOLAK topical products have Orange Book listings, and how do I check?
- Who typically supplies trolamine salicylate API for U.S. topical analgesics?
- Can TOLAK’s distributor change without changing the brand name?
- What procurement artifacts should a buyer request from a TOLAK supplier (GMP, COA, DMF references)?
References
- FDA (U.S. Food and Drug Administration). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. NDC Directory (National Drug Code). https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
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