Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Avedana Cool Hot Ice (Menthol) NDC 43749-321
Menthol 2 g/100g · Gel · Topical · Unipack, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43749-321-08 | 4374903210843749032108 | 227 g in 1 JAR (43749-321-08)Marketed from Nov 4, 2017 |
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)
- Avedana Cool Hot Ice
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 2 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Unipack, Inc.NDC labeler code 43749
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part348
- Marketing start
- Listing expires
- Identifiers
- Product ID 43749-321_1850af06-be68-45cd-a107-604506bef374SPL ID 1850af06-be68-45cd-a107-604506bef374SPL set ID 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3RxCUI 311502UNII L7T10EIP3AUPC 0751393006086
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
N443749032108followed by a unit qualifier and the quantityPackage 43749-0321-08. 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 Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises
Excerpt only. Read the full label for complete information.
About NDC 43749-321
- What is NDC 43749-321?
- 43749-321 is the product NDC for Avedana Cool Hot Ice (menthol), Menthol 2 g/100g gel, listed with the FDA by Unipack, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Avedana Cool Hot Ice (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Unipack, Inc., NDC labeler code 43749. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Avedana Cool Hot Ice?
- 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 part348
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 |
|---|---|---|---|---|
| Fire Outbenzocaine and menthol | Benzocaine 200 mg/mL; Menthol, Unspecified form 10 mg/mL | SolutionTopical | Randob Ltd. | 52412-300 |
| MediNumblidocaine | Lidocaine 40 mg/g | CreamTopical | Valekista Limited | 71383-024 |
| Deeveeant Numblidocaine | Lidocaine 40 mg/g | CreamTopical | Valekista Limited | 71383-014 |
| Intensive Healing Eczemahydrocortisone | Hydrocortisone 1.02 g/100g | LotionTopical | Walgreens | 0363-0670 |
| Cirlutonecamphor | Camphor (Synthetic) .6 g/100g | OintmentTopical | Herbal Health LLC | 71917-001 |
| Terocinlidocaine, menthol | Lidocaine 600 mg/1; Menthol, Unspecified form 600 mg/1 | PatchTopical | Preferred Pharmaceuticals, Inc. | 68788-9555 |
| CVS Pain Relieving First Aid Antisepticlidocaine hydrochloride, benzalkonium chloride | Lidocaine hydrochloride .025 g/g; Benzalkonium chloride .0013 g/g | SprayTopical | CVS Pharmacy | 69842-615 |
| New Terocinmethyl salicylate, capsaicin, and menthol | Methyl salicylate 25 g/100mL + 2 more ingredients | LotionTopical | Preferred Pharmaceuticals Inc. | 68788-7821 |
| Studio 35 External Analgesic Medicated Bodymenthol and zinc oxide | Menthol 1.5 mg/g; Zinc oxide 10 mg/g | PowderTopical | Walgreen Co | 0363-0552 |
| Rugby Muscle Rub Creammuscle rub cream | Menthol, Unspecified form 100 mg/g; Methyl salicylate 150 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8729 |
| Discount Drug Mart Regular Strength Itch Stoppingdiphenhydramine hydrochloride, zinc acetate | Diphenhydramine hydrochloride 10 mg/g; Zinc acetate 1 mg/g | CreamTopical | Discount Drug Mart | 53943-261 |
| Walgreens Camphor Phenol Gelcamphor, phenol | Camphor (Synthetic) 10.8 mg/g; Phenol 4.7 mg/g | GelTopical | Walgreens | 0363-9425 |
| Discount Drug Mart Anti-itchhydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | DISCOUNT DRUG MART, INC. | 53943-269 |
| CVS Sore Muscle Rub Vanishing Scentmenthol | Menthol .025 g/g | CreamTopical | CVS Pharmacy | 69842-712 |
| Fsk-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-170 |
| Pure-Aidlidocaine, menthol | Lidocaine 240 mg/1; Menthol, Unspecified form 60 mg/1 | PatchTopical | Kareway Product, Inc. | 67510-0284 |
| Ebsl-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-140 |
| Ebss-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-160 |
| Soundbodylidocaine, menthol | Lidocaine 40 mg/1; Menthol 10 mg/1 | PatchTopical | Kareway Product, Inc. | 67510-0636 |
| Iwk-5lidocaine hydrochloride | — | Kit | Water-Jel Technologies | 59898-180 |
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