Over-the-counter drug · OTC MONOGRAPH DRUG
Biofreeze Professional (Menthol, unspecified form) NDC 59316-115
Menthol, Unspecified form 50 mg/mL · Gel · Topical · Reckitt Benckiser LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)59316-115Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59316-0115Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59316-115-11 | 5931601151159316011511 | 3 mL in 1 PACKET (59316-115-11)Marketed from Jun 3, 2016 | |
| 59316-115-20 | 5931601152059316011520 | 118 mL in 1 TUBE (59316-115-20)Marketed from Jun 3, 2016 | |
| 59316-115-30 | 5931601153059316011530 | 473 mL in 1 BOTTLE (59316-115-30)Marketed from Jun 3, 2016 | |
| 59316-115-40 | 5931601154059316011540 | 946 mL in 1 BOTTLE (59316-115-40)Marketed from Jun 3, 2016 | |
| 59316-115-50 | 5931601155059316011550 | 3785 mL in 1 BOTTLE (59316-115-50)Marketed from Jun 3, 2016 | |
| 59316-115-82 | 5931601158259316011582 | 100 PACKET in 1 CARTON (59316-115-82) / 3 mL in 1 PACKETMarketed from Jan 5, 2019 |
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)
- Biofreeze Professional
- Generic name (nonproprietary)
- menthol, unspecified form
- Active ingredients
- Menthol, Unspecified form — 50 mg/mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Reckitt Benckiser LLCNDC labeler code 59316
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Identifiers
- Product ID 59316-115_51e07a73-db68-3e69-e063-6394a90a6bdbSPL ID 51e07a73-db68-3e69-e063-6394a90a6bdbSPL set ID 6bef9ccb-7a5a-4c67-b1bc-a92b167312daRxCUI 415975, 1794892UNII 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
N459316011511followed by a unit qualifier and the quantityPackage 59316-0115-11. 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 Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
Excerpt only. Read the full label for complete information.
About NDC 59316-115
- What is NDC 59316-115?
- 59316-115 is the product NDC for Biofreeze Professional, Menthol, Unspecified form 50 mg/mL gel, listed with the FDA by Reckitt Benckiser LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Biofreeze Professional (Menthol, Unspecified form).
- What is the active ingredient?
- Menthol, Unspecified form.
- Who is the labeler?
- Reckitt Benckiser LLC, NDC labeler code 59316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Biofreeze Professional?
- 5 other product NDCs are listed under this name. See all Biofreeze Professional NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Biofreeze Professional products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Biofreeze Professionalmenthol | Menthol 130 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-835 | 59316-0835-2059316-0835-22 |
| Biofreeze Professionalmenthol, unspecified form | Menthol, Unspecified form 105 mg/mL | Aerosol, SprayTopical | Reckitt Benckiser LLC | 59316-834 | 59316-0834-2059316-0834-22 |
| Biofreeze Professionalmenthol, unspecified form | Menthol 50 mg/mL | GelTopical | A-S Medication Solutions | 50090-6367 | 50090-6367-00 |
| Biofreeze Professionalmenthol, unspecified form | Menthol, Unspecified form 105 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-120 | 59316-0120-2059316-0120-30 |
| Biofreeze Professionalmenthol, unspecified form | Menthol, Unspecified form 50 mg/mL | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-4325 | 68071-4325-04 |
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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