Over-the-counter drug · OTC MONOGRAPH DRUG
Hot/Cold Menthol 16% Roll-On NDC 0395-9131
Menthol 16 mg/100mL · Liquid · Topical · Humco Holding Group, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0395-9131-97 | 0039591319700395913197 | 74 mL in 1 CONTAINER (0395-9131-97)Marketed from Dec 21, 2018 |
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)
- Hot/Cold Menthol 16% Roll-On
- Generic name (nonproprietary)
- hot/cold menthol 16% roll-on
- Active ingredients
- Menthol — 16 mg/100mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Humco Holding Group, IncNDC labeler code 0395
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 0395-9131_0c93883b-eed9-0f96-e063-6394a90ae9aaSPL ID 0c93883b-eed9-0f96-e063-6394a90ae9aaSPL set ID a8bf9744-9979-13c1-e053-2a95a90a30aaUNII L7T10EIP3A
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
N400395913197followed by a unit qualifier and the quantityPackage 00395-9131-97. 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)
Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.
Excerpt only. Read the full label for complete information.
About NDC 0395-9131
- What is NDC 0395-9131?
- 0395-9131 is the product NDC for Hot/Cold Menthol 16% Roll-On, Menthol 16 mg/100mL liquid, listed with the FDA by Humco Holding Group, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hot/Cold Menthol 16% Roll-On.
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Humco Holding Group, Inc, NDC labeler code 0395. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hot/Cold Menthol 16% Roll-On?
- 2 other product NDCs are listed under this name. See all Hot/Cold Menthol 16% Roll-On NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hot/Cold Menthol 16% Roll-On products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hot/Cold Menthol 16% Roll-On | Menthol 16 mg/100mL | LiquidTopical | Meijer, Inc. | 79481-0140 | 79481-0140-07 |
| Hot/Cold Menthol 16% Roll-On | Menthol 16 mg/100mL | LiquidTopical | Pharma Nobis, LLC | 82645-014 | 82645-0014-97 |
Other NDCs under M 017
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 |
|---|---|---|---|---|
| Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate | Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g | SprayTopical | Meijer Distribution Inc | 79481-0598 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Meijer Pain Relieving Balm Analgesictrolamine salicylate | Trolamine salicylate 10 mg/g | CreamTopical | Meijer Distribution, Inc | 41250-356 |
| Ralli Rapid Pain Relief Roll onmenthol | Menthol 100 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9527 |
| CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate | Camphor (Synthetic) 28 mg/1 + 2 more ingredients | PatchTransdermal | Natural Essentials, Inc. | 66902-280 |
| Pbz Otctripelennamine hcl 1% | Tripelennamine 1 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-151 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Henry Schein | 0404-0166 |
| American Safety and First Aidhydrocortisone acetate | Hydrocortisone acetate 10 mg/g | CreamTopical | Orazen Inc | 71927-015 |
| MyDerm Bite Reliefbenzocaine | Benzocaine 5 g/100g | OintmentTopical | Inspec Solutions LLC. | 72667-019 |
| Thera Plus Maximum Strength Hydrocortisonehydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Fourstar Group USA, Inc | 80684-197 |
| Lidocaine 4% | Lidocaine 400 mg/10g | PatchTransdermal | Marcella Health | 85096-201 |
| Tough Love Pain Relievinglidocaine hcl | Lidocaine 4 g/100g | CreamTopical | Allure Labs | 62742-4222 |
| Stopain Extra Strength Gelmenthol | Menthol 80 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9506 |
| Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol | Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL | LiquidTopical | Natural Essentials, Inc. | 66902-235 |
| Walgreens pain relievinglidocaine 4% | Lidocaine 4 g/100g | Aerosol, SprayTopical | Walgreens | 0363-3038 |
| Bikini Zone Medicated Cremelidocaine | Lidocaine 2 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-043 |
| American Safety First Aidlidocaine hcl | Lidocaine hydrochloride 20 mg/mL | SprayTopical | Orazen Inc | 71927-012 |
| ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-617 |
| Healmusz Eczemahydrocortisone 1% eczema | Hydrocortisone 1 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-203 |
| ELAIMEI Numbing Creamlidocaine 4% | Lidocaine 4 g/100mL | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-005 |
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