Over-the-counter drug · OTC MONOGRAPH DRUG

Antifungal Liquid (Tolnaftate) NDC 55319-538

Tolnaftate 10 mg/mL · Liquid · Topical · Family Dollar Services, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)55319-538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0538Add 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 NDC11-digit (billing)PackageCopy
55319-538-0155319053801553190538011 BOTTLE, WITH APPLICATOR in 1 CARTON (55319-538-01) / 30 mL in 1 BOTTLE, WITH APPLICATORMarketed from May 3, 2024

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)
Antifungal Liquid
Generic name (nonproprietary)
tolnaftate
Active ingredients
Tolnaftate — 10 mg/mL
Dosage form
Liquid
Route
Topical
Labeler
Family Dollar Services, IncNDC labeler code 55319
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Marketing end
Identifiers
Product ID 55319-538_3bcee78b-434d-e14d-e063-6394a90a6444SPL ID 3bcee78b-434d-e14d-e063-6394a90a6444SPL set ID 178e7b3f-949f-3f51-e063-6294a90a9395RxCUI 313423UNII 06KB629TKVUPC 0032251116971

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

N455319053801 followed by a unit qualifier and the quantity

Package 55319-0538-01. 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 .

Indications (excerpt from the label)

Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents the recurrence of most athlete's foot with daily use for effective relief of itching, burning, cracking, redness and scaling

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55319-538

What is NDC 55319-538?
55319-538 is the product NDC for Antifungal Liquid (tolnaftate), Tolnaftate 10 mg/mL liquid, listed with the FDA by Family Dollar Services, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Antifungal Liquid (Tolnaftate).
What is the active ingredient?
Tolnaftate.
Who is the labeler?
Family Dollar Services, Inc, NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Antifungal Liquid?
12 other product NDCs are listed under this name. See all Antifungal Liquid NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Antifungal Liquid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Antifungal LiquidtolnaftateTolnaftate 10 mg/gAerosol, SprayTopicalAmerisourceBergen Drug Corporation46122-83946122-0839-35
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalLEADER/ Cardinal Health 110, Inc.70000-074570000-0745-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalWal-Mart Stores, Inc.79903-39479903-0394-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalWalgreens Company0363-447100363-4471-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalTarget Corporation82442-99882442-0998-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalFamily Dollar Services, Inc55319-99555319-0995-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalPremier Brands of America Inc56104-90256104-0902-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalTarget Corporation82442-95682442-0956-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalTopCo Associates36800-39936800-0399-01
Antifungal LiquidtolnaftateTolnaftate 10 mg/mLLiquidTopicalWal-Mart Stores, Inc.79903-25679903-0256-30

All 13 Antifungal Liquid NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
CVS Health Athletes FoottolnaftateTolnaftate 10 mg/gCreamTopicalCVS Pharmacy, Inc.69842-336
TINGOLE FUNGAL NAIL Patchestolnaftate 1% fungal nail patchesTolnaftate 1 g/1001PatchTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-221
Wish Hand Sanitizer Coconut Cream White Floralsalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-108
Dr CANUSO fungal nail erasertolnaftate oilTolnaftate .3 g/28gOilTopicalRenu Laboratories, LLC76348-410
cmojsk TOENAIL FUNGUS PENundecylenic acid 25% tolnaftate 1% toenail fungus penTolnaftate 1 g/100mL; Undecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-220
Wish Hand Sanitizer Sweet Guava Fresh Coconutalcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-106
Wish Hand Sanitizer Dragonfruit Jasminealcohol hand sanitizerAlcohol 70 mL/100mLSprayTopicalPT SUPER HOME PRODUCT INDONESIA85537-107
Hongo KillertolnaftateTolnaftate .1 g/10gAerosol, PowderTopicalEfficient Laboratories Inc58593-285
PedikleertolnaftateTolnaftate 1 g/100gCreamTopicalRising Pharma Holdings, Inc.57237-354
Athletes Footmiconazole nitrateMiconazole nitrate 20 mg/gAerosol, PowderTopicalPremier Brands of America Inc56104-912
TolnaftateTolnaftate 10 mg/gCreamTopicalSheffield Pharmaceuticals LLC11527-051
THERA Antifungal Bodymiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalMcKesson Medical-Surgical Inc.68599-0207
LMNOOP MENS Private Health Creammens private health creamOatmeal 1 g/100gCreamTopicalShenzhen Ishan Technology Co., Ltd73076-210
Hermon Jock Itch Ringworm Athletes Foot Creammiconazole nitrateMiconazole nitrate 2 g/100gCreamTopicalBeautivity LLC85398-036
Antifungal Bodymiconazole nitrateMiconazole nitrate 2 mg/100mLCreamTopicalMcKesson68599-0206
LYSSERA Fungal Nail Renewalundecylenic acid 25% antifungaUndecylenic acid 25 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-174
Anti-Fungal Powdermiconazole nitrateMiconazole nitrate 20 mg/gPowderTopicalThe Kroger Co.30142-947
Hydrocortisone 1%hydrocortisoneHydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-329
Antifungal Medicated Body WashtolnaftateTolnaftate 1 g/100gGelTopicalRida LLC83004-012
Vamy ANTIFUNGALtolnaftate 1% antifungalTolnaftate 1 g/100mLSprayTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-176

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