Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Relieving (Menthol) NDC 61010-4403
Menthol 4 g/100g · Gel · Topical · Safetec of America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61010-4403-1 | 6101044030161010440301 | 113.4 g in 1 TUBE (61010-4403-1)Marketed from Nov 1, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Pain Relieving
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 4 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Safetec of America, Inc.NDC labeler code 61010
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 61010-4403_10aa8eb6-5d50-bea9-e063-6394a90a3623SPL ID 10aa8eb6-5d50-bea9-e063-6394a90a3623SPL set ID 52ebf64d-095f-467e-bf51-dd8d33b58c7dRxCUI 415974UNII 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
N461010440301followed by a unit qualifier and the quantityPackage 61010-4403-01. 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)
Use Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.
Excerpt only. Read the full label for complete information.
About NDC 61010-4403
- What is NDC 61010-4403?
- 61010-4403 is the product NDC for Pain Relieving (menthol), Menthol 4 g/100g gel, listed with the FDA by Safetec of America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Relieving (Menthol).
- What is the active ingredient?
- Menthol.
- Who is the labeler?
- Safetec of America, Inc., NDC labeler code 61010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Relieving?
- 5 other product NDCs are listed under this name. See all Pain Relieving NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Relieving products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Relievingtrolamine salicylate | Trolamine salicylate 100 mg/g | CreamTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0744 | 70000-0744-01 |
| Pain Relievinglidocaine | Lidocaine .04 g/g | PatchTopical | Medhome Pharma Inc | 84007-160 | 84007-0160-1584007-0160-30 |
| Pain Relievingcamphor (natural) | Camphor (Natural) 3.5 g/100mL | LinimentTopical | J.R. Watkins, LLC. | 72342-040 | 72342-0040-25 |
| Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 7 g/100mL | SprayTopical | Safetec of America, Inc. | 61010-1560 | 61010-1560-01 |
| Pain Relievingmenthol, camphor, capsaicin | Menthol 3.85 g/100mL + 2 more ingredients | LotionTopical | AHC VENTURES CORP DBA CRY | 68678-039 | 68678-0039-0468678-0039-1668678-0039-99 |
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 |
|---|---|---|---|---|
| Stopain Extra Strength Continuousmenthol | Menthol 80 mg/mL | SprayTopical | Troy Manufacturing, Inc. | 63936-4850 |
| Fast Freeze Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 33 mg/mL | GelTopical | NATURAL ESSENTIALS, INC. | 66902-116 |
| Walgreens Pain Reliefbenzocaine | Benzocaine 200 mg/g | GelOral | Walgreens Company | 0363-5061 |
| Blt 2lidocaine hcl | Lidocaine hydrochloride 4 g/100g | OintmentTopical | CENTURA PHARMACEUTICALS INC | 70372-728 |
| Lidocaine 4% Patchlidocaine 4% | Lidocaine 40 mg/g | PatchTopical | V2 Pharma, LLC | 72835-400 |
| Just Cbd Roll-On Coolingmenthol | Menthol 4 g/100mL | GelTopical | Just Brands LLC | 73647-400 |
| Magsoothium Body Cooling Formulamenthol | Menthol 5 g/100mL | CreamTopical | Ubu/Elements, Inc. | 83262-002 |
| Rapid Reliefpain relief patch camphor 110mg menthol 33mg capsicum extract 22mg | Levomenthol .3 g/100g + 2 more ingredients | PatchTopical | RAPID AID VIET NAM COMPANY LIMITED | 83569-015 |
| Terramed Just Think Comfort Hydrocortisone 1% Creamhydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Rida LLC | 83004-051 |
| Tktalker Numbingnumbing | Lidocaine 4 g/100g | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-113 |
| Herb Street Backache and Sore Muscle Reliefmenthol | Menthol .1 g/g | StickTopical | Balassa Laboratories Inc. | 10107-432 |
| CBD Pain Relief Creamtrolamine salicylate | Trolamine salicylate 100 mg/g | CreamTopical | Allure Labs | 62742-4198 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Hush Anestheticlidocaine | Lidocaine 40 mg/g | GelTopical | HUSH Anesthetic | 49947-002 |
| Jointivatrolamine salicylate 10% | Trolamine salicylate 10 g/100g | CreamTopical | Rising Pharma Holdings, Inc. | 57237-355 |
| Stopain Clinicalmenthol, unspecified form | Menthol, Unspecified form 100 mg/g | GelTopical | Troy Manufacturing, Inc. | 63936-0975 |
| Coralite Lidocaine 4% Flexible Pain Relief Patch 1ctlidocaine pain patch | Lidocaine 40 mg/g | PatchTopical | United Exchange Corp | 65923-579 |
| Desert Harvest RELEVEUMlidocaine | Lidocaine 40 mg/mL | CreamTopical | Desert Harvest Inc. | 69145-201 |
| A Health Itch Relief Gelitch relief gel | Diphenhydramine hydrochloride 2 mg/100mL | GelTopical | Bionpharma, Inc. | 69452-496 |
| Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylatetrolamine salicylate | Trolamine salicylate 10 g/100g | CreamTopical | TELEBRANDS CORP | 73287-032 |
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