NDC codes

FDA NDC Directory
Product NDC (as listed)0536-1315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1315Add 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
0536-1315-43005361315431 g in 1 BOX (0536-1315-43)Marketed from Mar 1, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
CR-371059 Tolnaftate 1% Cream
Generic name (nonproprietary)
cr-371059 tolnaftate 1% cream
Active ingredients
Tolnaftate — 1 g/100g
Dosage form
Cream
Route
Topical
Labeler
Rugby LaboratoriesNDC labeler code 0536
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 0536-1315_446ea5a8-c23d-43a6-e063-6294a90ab9bfSPL ID 446ea5a8-c23d-43a6-e063-6294a90ab9bfSPL set ID b95a76ad-9b4c-692a-e053-2995a90abd1aRxCUI 103951UNII 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

N400536131543 followed by a unit qualifier and the quantity

Package 00536-1315-43. 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 effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) • Helps prevent most athlete's foot with daily use • For effective relief of itching, burning, and cracking

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0536-1315

What is NDC 0536-1315?
0536-1315 is the product NDC for CR-371059 Tolnaftate 1% Cream, Tolnaftate 1 g/100g cream, listed with the FDA by Rugby Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
CR-371059 Tolnaftate 1% Cream.
What is the active ingredient?
Tolnaftate.
Who is the labeler?
Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CR-371059 Tolnaftate 1% Cream?
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
1% ketoconazoleketoconazoleKetoconazole 10 mg/mLShampooTopicalTAGRID LLC85384-0001
1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampooKetoconazole 1 g/100mLShampooCutaneousFast Sold LLC86241-110
1236-CS Antifungal Powder (Talc Free)1236-ccantifungal powder(talc free)Miconazole nitrate 20 mg/gPowderTopicalDynarex Corporation67777-313
2% MICONAZOLE NITRATE ANTIFUNGAL CreamMiconazole nitrate 2 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-025
4ozmiconazoleMiconazole 1.2 g/120gSoapTopicalNabrace LLC84056-003
5% Benzoyl Peroxide FOLLICULITIS CreamBenzoyl peroxide 5 g/100gCreamTopicalGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd84558-026
70% Isopropyl Alcoholisopropyl alcoholIsopropyl alcohol 70 g/100mLLiquidTopicalIDO PHARM77039-010
Activ-Charcoal AntifungaltolnaftateTolnaftate 1 g/100gSoapTopicalHONG KONG UNORDERED TRADING CO., LIMITED87800-0002
ADI Medical PVP-I Pouch, Foilpovidone-iodinePovidone-iodine 10 g/100gSolutionTopicalAsia Dynamics Inc., d/b/a ADI Medical83645-550
Aiilo NAIL FUNGUS TREATMENTundecylenic acid 25%Undecylenic acid .25 mg/30mLLiquidTopicalGuangzhou Huixue Biotechnology Co., Ltd.87204-190
Akin Anti-FungalclotrimazoleClotrimazole 10 mg/mLSolutionTopicalSouthern Sales & Service, Inc.69822-254
AlphaTip Nail Repair Pennail repair penUndecylenic acid 20 g/100mLLiquidTopicalGuangzhou Qiexiran Cosmetics Co., Ltd.85817-008
Alveora FOOT ODOR PROBIOTICtolnaftate 1% foot odor probioticTolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-030
Alveora NAIL FUNGUS TREATMENTTolnaftate 1 g/100mLLiquidTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-033
Amerfresh Antibacterial Deodorantbenzethonium chlorideBenzethonium chloride .1 g/100gSoapTopicalLiufangjing Biotechnology (Yangzhou) Co., Ltd85420-002
Anti DandruffketoconazoleKetoconazole 1 g/100mLShampooTopicalGuangzhou ChuanMa International Trading Co.,Ltd.85593-033
Anti- Fungal Miconazole Nitratemiconazole nitrateMiconazole nitrate 1.42 g/71gPowderTopicalPremier Brands of America Inc.56104-253
Anti-Bacterial HAND SANITIZERethyl alcoholAlcohol 63 mL/100mLGelTopicalDISNEY DESTINATIONS,LLC72707-029
Anti-Bacterial Wipesbenzalkonium chlorideBenzalkonium chloride .155 g/100gSolutionTopicalTongling Jieya Biological Technology Co., Ltd.50552-002
Anti-Fungalmiconazole nitrateMiconazole nitrate .02 g/gCreamTopicalUniversal Distribution Center LLC52000-021

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