Over-the-counter drug · OTC MONOGRAPH DRUG
Tolnaftate NDC 11527-051
Tolnaftate 10 mg/g · Cream · Topical · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-051-40 | 1152700514011527005140 | 1 TUBE in 1 CARTON (11527-051-40) / 35.4 g in 1 TUBEMarketed from Oct 7, 2009 | |
| 11527-051-51 | 1152700515111527005151 | 1 TUBE in 1 CARTON (11527-051-51) / 14 g in 1 TUBEMarketed from Oct 7, 2009 |
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)
- Tolnaftate
- Generic name (nonproprietary)
- tolnaftate
- Active ingredients
- Tolnaftate — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Sheffield Pharmaceuticals LLCNDC labeler code 11527
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Identifiers
- Product ID 11527-051_b4271182-7791-423e-8335-dfd5cb5d859bSPL ID b4271182-7791-423e-8335-dfd5cb5d859bSPL set ID ca52af37-c3a2-414c-a24a-a37a92925133RxCUI 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
N411527005140followed by a unit qualifier and the quantityPackage 11527-0051-40. 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 Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.
Excerpt only. Read the full label for complete information.
About NDC 11527-051
- What is NDC 11527-051?
- 11527-051 is the product NDC for Tolnaftate, Tolnaftate 10 mg/g cream, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tolnaftate.
- What is the active ingredient?
- Tolnaftate.
- Who is the labeler?
- Sheffield Pharmaceuticals LLC, NDC labeler code 11527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tolnaftate?
- 30 other product NDCs are listed under this name. See all Tolnaftate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tolnaftate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tolnaftateantifungal liquid spray | Tolnaftate 10 mg/g | Aerosol, SprayTopical | HY-VEE, INC | 42507-415 | 42507-0415-01 |
| Tolnaftateantifungal powder spray with baking soda | Tolnaftate 10 mg/g | Aerosol, PowderTopical | Target Corporation | 82442-402 | 82442-0402-01 |
| Tolnaftateantifungal liquid spray | Tolnaftate 10 mg/g | Aerosol, SprayTopical | Target Corporation | 82442-203 | 82442-0203-01 |
| Tolnaftateantifungal liquid spray | Tolnaftate 10 mg/g | Aerosol, SprayTopical | Chain Drug Marketing Association | 83324-237 | 83324-0237-53 |
| Tolnaftatemeijer athletes foot liquid | Tolnaftate 10 mg/g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0625 | 79481-0625-01 |
| Tolnaftatetolnaftate 1% | Tolnaftate 1 g/100g | CreamTopical | Trifecta Pharmaceuticals USA, LLC | 69396-130 | 69396-0130-01 |
| Tolnaftateantifungal spray liquid | Tolnaftate 10 mg/g | Aerosol, SprayTopical | FSA Store Inc. | 81522-068 | 81522-0068-01 |
| Tolnaftatetolnaftate powder spray | Tolnaftate 1.3 g/130g | Aerosol, SprayTopical | Kroger Co. | 30142-841 | 30142-0841-01 |
| Tolnaftatemeijer athletes foot liquid spray | Tolnaftate 1.5 g/150g | Aerosol, SprayTopical | Meijer Distribution Inc. | 79481-0591 | 79481-0591-01 |
| Tolnaftatetolnaftate athletes foot powder spray | Tolnaftate 1.3 g/130g | SprayTopical | Walgreens Company | 0363-1746 | 00363-1746-00 |
Other NDCs under M 005
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Terrasil Tinea Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-104 |
| Everywhere Flushable Wipes | Benzalkonium chloride .15 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-042 |
| Seacall Hydrocortisone Ointment.seacall hydrocortisone ointment | Hydrocortisone .1 g/100g | OintmentTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-006 |
| Fungal Nail Nighttime Renewal Patchestolnaftate 1% | Tolnaftate 1 g/1001 | PatchTopical | 100 KARMA INC | 85569-009 |
| Oiangna Tea Tree Oil Antifungalclotrimazole 1% | Clotrimazole 1 g/116g | SoapTopical | Guangzhou Huixue Biotechnology Co., Ltd. | 87204-285 |
| Eyelid Wipes | 4-terpineol .003 U/100U; Melaleuca alternifolia (Tea tree) leaf oil .04 U/100U | ClothTopical | Shenzhen Shierjie Biological Engineering Co., LTD | 43116-040 |
| CAREALL Clotrimazoleclotrimazole | Clotrimazole 10 g/g | CreamTopical | New World Imports, Inc | 51824-063 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Cardinal Health 110 dba LEADER | 70000-0667 |
| Gemachlich ZuHause Fungal Nail Revitalizer | Undecylenic acid 11 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-007 |
| Treatonic Toenail Fungus Treatment Kittoenail fungus treatment | — | KitTopical | 100 KARMA INC | 85569-010 |
| Fungal Nail Treatmentglacial acetic acid | Acetic acid 10.5 g/100mL | LiquidTopical | Guchutang Biotechnology (Longyan) Co., Ltd | 87083-020 |
| Good Neighbor Pharmacy Clotrimazoleclotrimazole | Clotrimazole 10 mg/g | CreamTopical | AmerisourceBergen | 24385-205 |
| Terrasil Ringworm Treatment MAXclotrimazole | Clotrimazole 1 g/100g | OintmentTopical | Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions | 24909-102 |
| Clotrimazolefamily wellness clotrimazole | Clotrimazole 1 g/100g | CreamTopical | Trifecta Pharmaceuticals USA LLC | 69396-038 |
| Paume Moisturizing Antibacterial Hand Gelalcohol | Alcohol 69 mL/100mL | GelTopical | Paume Inc | 80328-123 |
| Viachs ANTIFUNGAL Creammiconazole nitrate 2% antifungal cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-044 |
| Clotrimazole | Clotrimazole 1 g/100g | CreamTopical | A-S Medication Solutions | 50090-6546 |
| RoyceDerm ANTIFUNGAL .soap.clotrimazole 1% | Clotrimazole 2.26 g/226g | SoapTopical | RoyceDerm LLC | 85424-019 |
| 1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampoo | Ketoconazole 1 g/100mL | ShampooCutaneous | Fast Sold LLC | 86241-110 |
| Charmpoo ANTIFUNGAL BODY Creammiconazole nitrate 2% antifungal body cream | Miconazole nitrate 2 g/100g | CreamTopical | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 87786-042 |
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