NDC codes

FDA NDC Directory
Product NDC (as listed)63347-511Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63347-0511Add 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
63347-511-03633470511036334705110315 mL in 1 BOTTLE (63347-511-03)Marketed from Sep 19, 2012

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)
Tineacide
Generic name (nonproprietary)
tolnaftate
Active ingredients
Tolnaftate — 140 mg/15mL
Dosage form
Liquid
Route
Topical
Labeler
Blaine Labs Inc.NDC labeler code 63347
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 63347-511_7929e269-caee-4126-a9ba-14cbc2dd73d1SPL ID 7929e269-caee-4126-a9ba-14cbc2dd73d1SPL set ID 273eb424-5dc3-40c8-9ea7-2f732cbd11c9UNII 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

N463347051103 followed by a unit qualifier and the quantity

Package 63347-0511-03. 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)

Indications Indications Cures most athlete's foot (tinea pedis). Cures most jock itch (tinea cruris) and ring worm (tinea corporis). Relieves itching, cracking, burning, and scaling which accompany these conditions. Prevents most athlete's foot (tinea pedis) with daily use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63347-511

What is NDC 63347-511?
63347-511 is the product NDC for Tineacide (tolnaftate), Tolnaftate 140 mg/15mL liquid, listed with the FDA by Blaine Labs Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tineacide (Tolnaftate).
What is the active ingredient?
Tolnaftate.
Who is the labeler?
Blaine Labs Inc., NDC labeler code 63347. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tineacide?
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
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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