What is NDC 44577-128?

44577-128 is the product NDC for CLARUS AC Antifungal Solution (tolnaftate), Tolnaftate 10 mg/g liquid, listed with the FDA by Clinical Therapeutic Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

CLARUS AC Antifungal Solution (Tolnaftate).

Clinical Therapeutic Solutions, NDC labeler code 44577. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for CLARUS AC Antifungal Solution?

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.

CLARUS AC Antifungal Solution NDC 44577-128

NDC codes

FDA NDC Directory

Product NDC (as listed)44577-128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44577-0128Add 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
44577-128-00	4457701280044577012800	15 g in 1 TUBE (44577-128-00)Marketed from Mar 1, 2021

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): CLARUS AC Antifungal Solution
Generic name (nonproprietary): tolnaftate
Active ingredients: Tolnaftate — 10 mg/g
Dosage form: Liquid
Route: Topical
Labeler: Clinical Therapeutic SolutionsNDC labeler code 44577
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 005
Marketing start: Mar 1, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 44577-128_09d7052e-ec64-ef60-e063-6294a90af214SPL ID 09d7052e-ec64-ef60-e063-6294a90af214SPL set ID 28ab9f1b-65cd-4405-a9a3-f3c9b836693dRxCUI 313423UNII 06KB629TKV

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

N444577012800 followed by a unit qualifier and the quantity

Package 44577-0128-00. 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 Nov 10, 2023.

Indications (excerpt from the label)

Uses: Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm). For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections. Prevents most tinea pedis (athlete's foot) with daily use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44577-128

What is NDC 44577-128?: 44577-128 is the product NDC for CLARUS AC Antifungal Solution (tolnaftate), Tolnaftate 10 mg/g liquid, listed with the FDA by Clinical Therapeutic Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: CLARUS AC Antifungal Solution (Tolnaftate).
What is the active ingredient?: Tolnaftate.
Who is the labeler?: Clinical Therapeutic Solutions, NDC labeler code 44577. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CLARUS AC Antifungal Solution?: 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
Lavender Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-015
Sefudun Fungal Nail Patchesglycerin	Glycerin .01 g/1	PatchTopical	Shenzhen Shandian Jingling Technology Co., Ltd.	83804-006
Hongo Killertolnaftate	Miconazole nitrate .2 g/10g	Aerosol, SprayTopical	Efficient Laboratories Inc	58593-625
Lights Isopropyl Alcohol Prep Padsisopropyl alcohol	Isopropyl alcohol 70 mL/100mL	SolutionTopical	Lights Medical Manufacture Co., Ltd.	61333-206
Miconazole Nitrate	Miconazole nitrate 20 mg/g	CreamTopical	STRATEGIC SOURCING SERVICES LLC	70677-1000
Tolnaftatemeijer athletes foot liquid spray	Tolnaftate 1.5 g/150g	Aerosol, SprayTopical	Meijer Distribution Inc.	79481-0591
Mint Blast Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-013
NATURAL CURES FUNGAL NAIL Patchestolnaftate 1% fungal nail patches	Tolnaftate 1 g/1001	PatchTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-202
Benzo Dermabenzoic acid, salicylic acid, sulfur	Salicylic acid 2.5 g/100g + 2 more ingredients	CreamTopical	LABORATORIOS H.G. C.A.	84058-130
SUNMARK MICONAZOLE NITRATE antifungalmiconazole nitrate	Miconazole nitrate 20 mg/g	CreamTopical	Strategic Sourcing Services LLC	49348-689
Hongo Killertolnaftate	Tolnaftate 1 g/100g	PowderTopical	Efficient Laboratories Inc	58593-288
Mycozyl ALtolnaftate	Tolnaftate .3 g/30mL	LiquidTopical	PureTek Corporation	59088-443
Tolnaftate Cream 1%tolnaftate	Tolnaftate 10 mg/g	CreamTopical	Pharmacy Value Alliance, LLC.	68016-152
Citrus Detox Foot and Shoe Antifungalundecylenic acid 10%	Undecylenic acid 10 g/100mL	SprayTopical	SANSAR, LLC	83691-014
Antifungal Ringworm Treatmentmiconazole nitrate	Miconazole nitrate 2 g/100mL	SprayTopical	Rida LLC	83004-030
Jock-Ezeclotrimazole	Clotrimazole 10 mg/g	CreamTopical	Bentlin Products LLC	47832-071
Maximum Strength Antifungal Liquidtolnaftate	Tolnaftate 10 mg/mL	LiquidTopical	Walgreens Company	0363-2026
QualiLife persimmon foot and shoeundecylenic acid	Undecylenic acid 10 g/100mL	SprayTopical	Guangdong Aimu Biological Technology Co., Ltd	83566-618
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Treetolnaftate	Tolnaftate 1 g/100g	GelTopical	Rida LLC	83004-032
Kakalsa TOENAIL FUNGUS TREATMENTundecylenic acid 25% toenail fungus treatment	Undecylenic acid 25 g/100mL	LiquidTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-204

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CLARUS AC Antifungal Solution (Tolnaftate) NDC 44577-128