Over-the-counter drug · OTC MONOGRAPH DRUG
Claravie (Miconazole nitrate) NDC 61554-305
Miconazole nitrate 2 g/100g · Cream · Topical · Gentell LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61554-305-11 | 6155403051161554030511 | 113 g in 1 TUBE (61554-305-11)Marketed from Aug 20, 2026 | |
| 61554-305-21 | 6155403052161554030521 | 5 g in 1 PACKET (61554-305-21)Marketed from Aug 20, 2026 |
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)
- Claravie
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 2 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Gentell LLCNDC labeler code 61554
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 005
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 61554-305_596d590b-e800-4be3-e063-6294a90a871dSPL ID 596d590b-e800-4be3-e063-6294a90a871dSPL set ID 596d590b-e7ff-4be3-e063-6294a90a871dRxCUI 998483UNII VW4H1CYW1KUPC 0361554011134
- Pharmacologic class
- Azole Antifungal
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
N461554030511followed by a unit qualifier and the quantityPackage 61554-0305-11. 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 Jock itch Rinqworm Relieves itching, scaling, cracking and discomfort that can accompany these conditions
Excerpt only. Read the full label for complete information.
About NDC 61554-305
- What is NDC 61554-305?
- 61554-305 is the product NDC for Claravie (miconazole nitrate), Miconazole nitrate 2 g/100g cream, listed with the FDA by Gentell LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Claravie (Miconazole Nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Gentell LLC, NDC labeler code 61554. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Claravie?
- 15 other product NDCs are listed under this name. See all Claravie NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Claravie products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Claraviemiconazole nitrate 2% | Miconazole nitrate 2 g/100g | PowderTopical | Gentell LLC | 61554-316 | 61554-0316-41 |
| Claraviealuminum sesquichlorohydrate 15% | Aluminum sesquichlorohydrate 15 g/100g | Aerosol, SprayTopical | Gentell LLC | 61554-317 | 61554-0317-41 |
| Claraviealuminum hydroxide gel | Aluminum hydroxide 2 g/100g | OintmentTopical | Gentell LLC | 61554-318 | 61554-0318-11 |
| Claraviebacitracin zinc | Bacitracin zinc 500 U/g | OintmentTopical | Gentell LLC | 61554-310 | 61554-0310-1161554-0310-21 |
| Claraviedimethicone | Dimethicone 5 g/100g | OintmentTopical | Gentell LLC | 61554-313 | 61554-0313-11 |
| Claraviehydrocortisone acetate | Hydrocortisone acetate 1 g/100g | CreamTopical | Gentell LLC | 61554-311 | 61554-0311-1161554-0311-2161554-0311-31 |
| Claraviezinc oxide, dimethicone | Zinc oxide 12 g/100g; Dimethicone 1 g/100g | CreamTopical | Gentell LLC | 61554-312 | 61554-0312-11 |
| Claraviebenzalkonium chloride | Benzalkonium chloride .1 g/100mL | LotionTopical | Gentell LLC | 61554-315 | 61554-0315-41 |
| Claraviecamphor | Camphor (Natural) 5 g/1000g | CreamTopical | Gentell LLC | 61554-308 | 61554-0308-41 |
| Claraviebacitracin zinc, neomycin sulfate, polymyxin b | Bacitracin zinc 400 U/g + 2 more ingredients | OintmentTopical | Gentell LLC | 61554-309 | 61554-0309-1161554-0309-21 |
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 |
|---|---|---|---|---|
| Tolnafatetolnaftate athletes foot powder spray talc free | Tolnaftate 1.3 g/130g | Aerosol, SprayTopical | VALU MERCHANDISERS, CO | 63941-541 |
| U Hand Sanitizer Classicbenzalkonium chloride | Benzalkonium chloride .13 g/100mL | SolutionTopical | BLUE SEA AEROSOL & DAILY CARE CO., LTD | 72119-004 |
| Gembooxt Nail Fungus Solution | Undecylenic acid 11 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-016 |
| Nailtific Nighttime Antifungal Renewal Pen Refilltolnaftate | Tolnaftate .06 g/6mL | LiquidTopical | Guangzhou Meixi Biotechnology Co., Ltd. | 84167-023 |
| UKVOA Toenail Fungus Treatmenttolnaftate 1% fungi nail | Tolnaftate 1 g/100mL | LiquidTopical | Jiashen International Trade Limited | 84867-012 |
| Tegasolve Toenail Fungus Treatmentundecylenic acid 25% | Undecylenic acid 25 g/100mL | LiquidTopical | Zhengzhou Hangrui Network Technology Co., Ltd. | 85578-003 |
| Tuymec Antifungal Medicated Barantifungal medicated bar | Clotrimazole 1 g/100g | SoapTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-010 |
| Lotrimin Daily Preventiontolnaftate | Tolnaftate 10 mg/g | PowderTopical | Bayer HealthCare LLC. | 11523-0011 |
| Green Tetterinemiconazole nitrate | Miconazole nitrate 2 g/100g | OintmentTopical | S.S.S. Company | 12258-241 |
| COTTON ON FOUNDATION Coastal Hand Sanitizerethyl alcohol | Alcohol 75 mL/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-052 |
| VORVITA Nail Hardenerpanthenol,hyaluronic acid | Hyaluronic acid 1 g/10000mL; Panthenol 10 g/10000mL | SolutionTopical | HK Vorvita Technology Co., Limited | 87690-001 |
| MOROVANJock Itch Antifungalmiconazole nitrate | Miconazole nitrate 2 g/100g | CreamTopical | HONG KONG UNORDERED TRADING CO., LIMITED | 87800-0006 |
| White Tetterinemiconazole nitrate | Miconazole nitrate 2 g/100g | OintmentTopical | S.S.S. Company | 12258-242 |
| Bluesea Disposable Hand Sanitizeralcohol | Alcohol 75 mL/100mL | SolutionTopical | BLUE SEA AEROSOL & DAILY CARE CO., LTD | 72119-002 |
| Nailtific Daytime Treatment Antifungal Pen Refill | Undecylenic acid 1.5 g/6mL; Tolnaftate .06 g/6mL | LiquidTopical | Guangzhou Meixi Biotechnology Co., Ltd. | 84167-012 |
| Skin Tag Wart And Corn Removersalicylic acid | Salicylic acid 17 g/100g | LiquidCutaneous, Extracorporeal, Topical | Zhenping Renren Industry Co., Ltd. | 87096-001 |
| Lakeim FUNGAL NAIL RENEWAL Kitfungal nail renewal kit | Undecylenic acid 25 g/100mL | LiquidTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-009 |
| Tingole Fungal Nail Patchesfungal nail patches | Tolnaftate 1 g/1001 | PatchTopical | Xiamen Jingwei Supply Chain Management Co., Ltd | 88010-002 |
| Tolnafatetolnaftate jock itch powder spray - talc free | Tolnaftate 1.3 g/130g | Aerosol, SprayTopical | VALU MERCHANDISERS, CO. | 63941-540 |
| Bluesea Instant Hand Sanitizeralcohol | Alcohol 70 mL/100mL | SolutionTopical | BLUE SEA AEROSOL & DAILY CARE CO., LTD | 72119-003 |
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