Last updated: April 24, 2026
Who Supplies “Monistat 1 Combination Pack” (Miconazole) and How to Identify the Likely Manufacturers?
Suppliers for “Monistat 1 Combination Pack” are not uniquely determined from the product name alone. “Monistat 1 Combination Pack” is a consumer-facing label that bundles multiple dosage forms (typically a cream and an external applicator product) under the brand “Monistat,” and the underlying drug substance is miconazole. For procurement, manufacturing, and IP due diligence, the supplier mapping must be done at the NDC level (labeler) and then to the manufacturer(s) listed on the carton/insert or the FDA Orange Book/NDC directory entries tied to that specific NDC.
The actionable path used in pharmaceutical sourcing and patent analytics is:
1) Resolve the exact NDC(s) for the specific “Monistat 1 Combination Pack” SKU (strength and pack configuration).
2) Use the NDC labeler and manufacturer fields to identify the actual labeler and site(s) of manufacture that correspond to that NDC.
3) Cross-check whether the product is a single-source brand or a repackaged/relabeled assortment by comparing labeler vs. manufacturer fields across the NDC directory records.
What drug product is “Monistat 1 Combination Pack” supplying?
“Monistat 1” products contain miconazole, typically miconazole nitrate in antifungal formulations for vulvovaginal candidiasis. The “combination pack” format reflects multiple components rather than a single unit dose.
Key sourcing implication: even when the active ingredient is the same (miconazole), the “combination pack” can involve different manufacturing lines/sites for each dosage form (internal vaginal product vs. external cream, applicators, or wipes/cleanser components depending on the SKU).
Who are the suppliers (labeler/manufacturer) behind Monistat 1 Combination Pack?
The supplier identification requires an NDC-specific lookup. The FDA’s NDC Directory is the canonical record that ties a product to a labeler and a manufacturer for that exact NDC. The same brand name can map to multiple NDCs across dosage strengths and pack configurations, and supplier fields can change accordingly. (FDA NDC Directory is the source used to map “who makes it” for a specific SKU.) [1]
Procurement-ready supplier mapping workflow
Use this to extract the supplier list for the exact Monistat 1 Combination Pack SKU:
- Identify the NDC from the outer carton or package insert.
- Pull the record from the FDA NDC Directory:
- Labeler (marketing authorization holder in the NDC sense)
- Manufacturer (site and/or firm that manufactures the product for that NDC record)
- If multiple NDCs exist for “combination pack” SKUs, repeat the above for each NDC.
This produces a definitive supplier list at the SKU level, which is what buyers and investors need for vendor qualification, cost modeling, and supply risk.
Why supplier attribution cannot be done from “Monistat 1 Combination Pack” alone
- “Monistat 1” is a brand line with multiple strengths/configurations.
- “Combination Pack” changes the packaging and can change the NDC and manufacturer mapping.
- The FDA NDC Directory can show different manufacturer entries even under the same brand umbrella due to:
- different dosage forms in the pack
- different production sites
- different labeler/manufacturer relationships by NDC record.
Without the specific NDC, any “supplier list” would be non-actionable because it risks naming the wrong manufacturing site for the exact SKU being purchased or analyzed.
How to turn this into a supplier list you can put in a PO or due diligence deck
Deliverables you should extract per exact NDC
For each NDC mapped to “Monistat 1 Combination Pack”:
- Labeler name
- Manufacturer name
- Manufacturing location (if provided in the NDC record)
- Dosage form and strength (to confirm SKU match)
- Package type (to confirm it is the “combination pack” configuration)
Example supplier table template (fill with NDC data)
| NDC |
Monistat 1 Combination Pack Variant |
Labeler (NDC) |
Manufacturer (NDC) |
Dosage Form |
Strength |
| [NDC #] |
[variant] |
[labeler] |
[manufacturer] |
[dosage form] |
[strength] |
This is the standard structure used to reconcile procurement, manufacturing contracts, and IP ownership at SKU granularity.
What about patent/IP suppliers and “who owns the product”?
Supplier (manufacturing) and IP (application/market exclusivity and patent ownership) often diverge. For patent analysis you typically:
- identify the active ingredient(s) and drug product in the FDA Orange Book
- map the listed drug (RLD) to brand entries and manufacturers
- compare Orange Book “applicant/holder” data to NDC labeler/manufacturer data.
This separates:
- who manufactures (NDC manufacturer field)
- who holds regulatory responsibility (Orange Book applicant/holder)
- who owns relevant patents (Orange Book listed patents tied to the RLD) [2]
The “Monistat 1 Combination Pack” brand name alone cannot be reliably mapped to a single RLD entry without the exact formulation and NDC.
Key Takeaways
- Supplier identification for “Monistat 1 Combination Pack” must be NDC-specific.
- The FDA NDC Directory is the authoritative source to pull labeler and manufacturer for the exact SKU. [1]
- For IP and regulatory ownership, you reconcile NDC mapping with the FDA Orange Book entries for the matching RLD/formulation. [2]
- Any supplier list that is not anchored to the exact NDC(s) risks misidentifying the manufacturing site tied to the specific “combination pack” being supplied.
FAQs
1) Is the supplier the same for every “Monistat 1 Combination Pack” SKU?
No. “Monistat 1” spans multiple NDCs and pack configurations, and NDC manufacturer fields can differ by strength and packaging.
2) Where do I find the supplier names for the exact pack I’m sourcing?
Use the NDC printed on the package and query the FDA NDC Directory for that NDC record. [1]
3) Does the labeler equal the manufacturer?
Often they are different. The NDC Directory records both a labeler and a manufacturer and either can differ by NDC.
4) If I’m doing patent due diligence, do I use the same supplier list?
Not necessarily. Patent/regulatory responsibility maps through Orange Book RLD/applicant/holder entries, which can differ from NDC manufacturer. [2]
5) Can I identify suppliers from “Monistat 1 Combination Pack” alone (no NDC)?
Not in a procurement-grade way. NDC resolution is the minimum step to produce an accurate supplier list.
References
[1] U.S. Food and Drug Administration. (n.d.). NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
[2] U.S. Food and Drug Administration. (n.d.). Drugs@FDA / Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
