Suppliers and packagers for LOTRIMIN ULTRA

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LOTRIMIN ULTRA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-0082-1	1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR	2021-12-20
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-0158-2	1 TUBE in 1 CARTON (11523-0158-2) / 30 g in 1 TUBE	2024-01-02
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-4338-1	1 TUBE in 1 CARTON (11523-4338-1) / 12 g in 1 TUBE	2002-02-22
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-4338-2	1 TUBE in 1 CARTON (11523-4338-2) / 15 g in 1 TUBE	2002-02-22
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-4338-4	1 TUBE in 1 CARTON (11523-4338-4) / 30 g in 1 TUBE	2002-02-22
Bayer Healthcare Llc	LOTRIMIN ULTRA	butenafine hydrochloride	CREAM;TOPICAL	021307	NDA	Bayer Healthcare LLC.	11523-4339-1	1 TUBE in 1 CARTON (11523-4339-1) / 12 g in 1 TUBE	2002-02-22

LOTRIMIN ULTRA Supplier List: Who Makes and Distributes This OTC Topical Antifungal?

Last updated: June 10, 2026

Who are the suppliers for LOTRIMIN ULTRA (clotrimazole) in the US supply chain?

No sufficient, source-backed information is available to produce a complete and accurate supplier list for LOTRIMIN ULTRA. Without verifiable details tied to the specific branded product (strength, dosage form, NDC/labeler, and US distribution status), naming “suppliers” would be incomplete and error-prone.

Which companies supply clotrimazole topical “ultra” products for LOTRIMIN ULTRA?

No complete, source-validated mapping of LOTRIMIN ULTRA to manufacturer/labeler and upstream API or finished-dose suppliers is available in the provided information.

What is the Orange Book status of LOTRIMIN ULTRA, and does it indicate any listed manufacturers?

OTC topical antifungals like LOTRIMIN ULTRA generally are not listed in the FDA Orange Book in the same way as prescription drug products, and no product-specific Orange Book data is available here to identify labelers or patent holders.

Which NDC/labeler is used for LOTRIMIN ULTRA, and who is the labeler of record?

A supplier-grade answer requires the product’s NDC and labeler name (the FDA “Labeler” for finished dose). That data is not provided, so a supplier list cannot be generated without risking incorrect attributions.

What API suppliers produce clotrimazole for topical antifungals like LOTRIMIN ULTRA?

No source-backed API supplier roster for the specific LOTRIMIN ULTRA market presentation is available in the provided information.

How do manufacturing and distribution responsibilities usually split for OTC clotrimazole products?

A reliable split depends on the labeler and the finished-dose manufacturer for the specific NDC. That product-specific linkage is not available here.

What generic or private-label clotrimazole “ultra” versions compete with LOTRIMIN ULTRA, and who supplies them?

A competitor supplier map requires identification of matching strength/dosage form and their NDC labelers, which is not available here.

Which regulatory filings (FDA OTC drug listing) would name manufacturers for LOTRIMIN ULTRA?

FDA OTC drug establishment and listing details can identify listed manufacturers and contact entities, but no filing identifiers are provided for LOTRIMIN ULTRA.

Key Takeaways

• A supplier-grade list for LOTRIMIN ULTRA requires product-specific identity (NDC/labeler, strength, dosage form).
• With no verifiable product-specific data provided, it is not possible to produce an accurate upstream API and finished-dose supplier roster.

FAQs

1. What does “ultra” mean for LOTRIMIN ULTRA clotrimazole products?
2. How can I identify the FDA labeler/manufacturer for LOTRIMIN ULTRA?
3. Are OTC clotrimazole products covered by the FDA Orange Book?
4. Do private-label antifungal “clotrimazole ultra” products come from the same manufacturers as branded LOTRIMIN?
5. What records show upstream API suppliers for topical clotrimazole?

References

No sources were provided in the prompt, and no product-specific verifiable data (e.g., NDC labeler/manufacturer) is included to cite.