What is NDC 85578-003?

85578-003 is the product NDC for Tegasolve Toenail Fungus Treatment, Undecylenic acid 25 g/100mL liquid, listed with the FDA by Zhengzhou Hangrui Network Technology Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tegasolve Toenail Fungus Treatment (Undecylenic Acid 25%).

Zhengzhou Hangrui Network Technology Co., Ltd., NDC labeler code 85578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tegasolve Toenail Fungus Treatment?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tegasolve Toenail Fungus Treatment NDC 85578-003

NDC codes

FDA NDC Directory

Product NDC (as listed)85578-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85578-0003Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85578-003-01	8557800030185578000301	1 BOTTLE in 1 BOX (85578-003-01) / 30 mL in 1 BOTTLEMarketed from Jun 12, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tegasolve Toenail Fungus Treatment
Generic name (nonproprietary): undecylenic acid 25%
Active ingredients: Undecylenic acid — 25 g/100mL
Dosage form: Liquid
Route: Topical
Labeler: Zhengzhou Hangrui Network Technology Co., Ltd.NDC labeler code 85578
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Jun 12, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 85578-003_375b0515-1b20-23b8-e063-6294a90a9d68SPL ID 375b0515-1b20-23b8-e063-6294a90a9d68SPL set ID 375b0515-1b1f-23b8-e063-6294a90a9d68RxCUI 998329UNII K3D86KJ24N

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N485578000301 followed by a unit qualifier and the quantity

Package 85578-0003-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 12, 2025.

Indications (excerpt from the label)

For the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85578-003

What is NDC 85578-003?: 85578-003 is the product NDC for Tegasolve Toenail Fungus Treatment, Undecylenic acid 25 g/100mL liquid, listed with the FDA by Zhengzhou Hangrui Network Technology Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tegasolve Toenail Fungus Treatment (Undecylenic Acid 25%).
What is the active ingredient?: Undecylenic acid.
Who is the labeler?: Zhengzhou Hangrui Network Technology Co., Ltd., NDC labeler code 85578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tegasolve Toenail Fungus Treatment?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 005

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 005
Product	Strength	Form · route	Labeler	Product NDC
Tolnafatetolnaftate athletes foot powder spray talc free	Tolnaftate 1.3 g/130g	Aerosol, SprayTopical	VALU MERCHANDISERS, CO	63941-541
U Hand Sanitizer Classicbenzalkonium chloride	Benzalkonium chloride .13 g/100mL	SolutionTopical	BLUE SEA AEROSOL & DAILY CARE CO., LTD	72119-004
Gembooxt Nail Fungus Solution	Undecylenic acid 11 g/100mL	LiquidTopical	Guangdong Quadrant Ecological Technology Co., Ltd.	76986-016
Nailtific Nighttime Antifungal Renewal Pen Refilltolnaftate	Tolnaftate .06 g/6mL	LiquidTopical	Guangzhou Meixi Biotechnology Co., Ltd.	84167-023
UKVOA Toenail Fungus Treatmenttolnaftate 1% fungi nail	Tolnaftate 1 g/100mL	LiquidTopical	Jiashen International Trade Limited	84867-012
Tuymec Antifungal Medicated Barantifungal medicated bar	Clotrimazole 1 g/100g	SoapTopical	Guangzhou Jingliang Cosmetics Co., Ltd.	87408-010
Lotrimin Daily Preventiontolnaftate	Tolnaftate 10 mg/g	PowderTopical	Bayer HealthCare LLC.	11523-0011
Green Tetterinemiconazole nitrate	Miconazole nitrate 2 g/100g	OintmentTopical	S.S.S. Company	12258-241
COTTON ON FOUNDATION Coastal Hand Sanitizerethyl alcohol	Alcohol 75 mL/100mL	SprayTopical	Nantong Health & Beyond Hygienic Products Inc.	43473-052
VORVITA Nail Hardenerpanthenol,hyaluronic acid	Hyaluronic acid 1 g/10000mL; Panthenol 10 g/10000mL	SolutionTopical	HK Vorvita Technology Co., Limited	87690-001
MOROVANJock Itch Antifungalmiconazole nitrate	Miconazole nitrate 2 g/100g	CreamTopical	HONG KONG UNORDERED TRADING CO., LIMITED	87800-0006
White Tetterinemiconazole nitrate	Miconazole nitrate 2 g/100g	OintmentTopical	S.S.S. Company	12258-242
Bluesea Disposable Hand Sanitizeralcohol	Alcohol 75 mL/100mL	SolutionTopical	BLUE SEA AEROSOL & DAILY CARE CO., LTD	72119-002
Nailtific Daytime Treatment Antifungal Pen Refill	Undecylenic acid 1.5 g/6mL; Tolnaftate .06 g/6mL	LiquidTopical	Guangzhou Meixi Biotechnology Co., Ltd.	84167-012
Skin Tag Wart And Corn Removersalicylic acid	Salicylic acid 17 g/100g	LiquidCutaneous, Extracorporeal, Topical	Zhenping Renren Industry Co., Ltd.	87096-001
Lakeim FUNGAL NAIL RENEWAL Kitfungal nail renewal kit	Undecylenic acid 25 g/100mL	LiquidTopical	Guangzhou Jingliang Cosmetics Co., Ltd.	87408-009
Tingole Fungal Nail Patchesfungal nail patches	Tolnaftate 1 g/1001	PatchTopical	Xiamen Jingwei Supply Chain Management Co., Ltd	88010-002
Tolnafatetolnaftate jock itch powder spray - talc free	Tolnaftate 1.3 g/130g	Aerosol, SprayTopical	VALU MERCHANDISERS, CO.	63941-540
Bluesea Instant Hand Sanitizeralcohol	Alcohol 70 mL/100mL	SolutionTopical	BLUE SEA AEROSOL & DAILY CARE CO., LTD	72119-003
Ukova Foot Odor Probiotictolnaftate 1% fungi nail	Tolnaftate 1 g/100mL	LiquidTopical	Jiashen International Trade Limited	84867-011

Showing 20 of 39.

Tegasolve Toenail Fungus Treatment (Undecylenic acid 25%) NDC 85578-003