Over-the-counter drug · OTC MONOGRAPH DRUG
Biofreeze Professional (Menthol, unspecified form) NDC 59316-834
Menthol, Unspecified form 105 mg/mL · Aerosol, Spray · Topical · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59316-834-20 | 5931608342059316083420 | 118 mL in 1 BOTTLE (59316-834-20)Marketed from Feb 1, 2024 | |
| 59316-834-22 | 5931608342259316083422 | 2 BOTTLE in 1 CARTON (59316-834-22) / 118 mL in 1 BOTTLE (59316-834-20)Marketed from Mar 15, 2025 |
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 — 105 mg/mL
- Dosage form
- Aerosol, Spray
- 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 59316-834_51e066bd-7c9d-326a-e063-6394a90a28b1SPL ID 51e066bd-7c9d-326a-e063-6394a90a28b1SPL set ID 00bba5d2-b0e0-701c-e063-6294a90a5741RxCUI 1489073, 1489074UNII L7T10EIP3AUPC 0359316120200
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
N459316083420followed by a unit qualifier and the quantityPackage 59316-0834-20. 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 59316-834
- What is NDC 59316-834?
- 59316-834 is the product NDC for Biofreeze Professional, Menthol, Unspecified form 105 mg/mL aerosol, spray, listed with the FDA by Reckitt Benckiser LLC. It has 2 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 50 mg/mL | GelTopical | A-S Medication Solutions | 50090-6367 | 50090-6367-00 |
| Biofreeze Professionalmenthol, unspecified form | Menthol, Unspecified form 50 mg/mL | GelTopical | Reckitt Benckiser LLC | 59316-115 | 59316-0115-1159316-0115-2059316-0115-30+3 more |
| 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 |
|---|---|---|---|---|
| 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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