Over-the-counter drug · OTC MONOGRAPH DRUG
Biofreeze (Menthol) NDC 59316-833
Menthol 105 mg/mL · Spray · Topical · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59316-833-10 | 59316083310 | 89 mL in 1 BOTTLE (59316-833-10)Marketed from Dec 1, 2023 | |
| 59316-833-20 | 59316083320 | 118 mL in 1 BOTTLE (59316-833-20)Marketed from Jan 1, 2026 |
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
- Generic name (nonproprietary)
- menthol
- Active ingredients
- Menthol — 105 mg/mL
- Dosage form
- 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 59316-833_51b57ded-2d7c-d540-e063-6394a90a4744SPL ID 51b57ded-2d7c-d540-e063-6394a90a4744SPL set ID 00bb462a-27d0-6f74-e063-6394a90a90ecRxCUI 1489073, 1489074UNII 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
N459316083310followed by a unit qualifier and the quantityPackage 59316-0833-10. 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 Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis backache strains and sprains
Excerpt only. Read the full label for complete information.
About NDC 59316-833
- What is NDC 59316-833?
- 59316-833 is the product NDC for Biofreeze (menthol), Menthol 105 mg/mL 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 (Menthol).
- What is the active ingredient?
- Menthol.
- 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?
- 6 other product NDCs are listed under this name. See all Biofreeze NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Biofreeze products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Biofreezementhol | Menthol, Unspecified form 100 mg/g | CreamTopical | Reckitt Benckiser LLC | 59316-870 | 59316-0870-10 |
| Biofreezementhol | Menthol, Unspecified form 100 mg/g | CreamTopical | Reckitt Benckiser LLC | 59316-869 | 59316-0869-10 |
| Biofreezementhol | Menthol, Unspecified form 35 mg/mL | GelTopical | Reckitt Benckiser LLC | 59316-101 | 59316-0101-1059316-0101-1159316-0101-12+7 more |
| Biofreezementhol | Menthol, Unspecified form 105 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-114 | 59316-0114-1059316-0114-2559316-0114-30 |
| Biofreezementhol | Menthol, Unspecified form 40 mg/mL | GelTopical | Reckitt Benckiser LLC | 59316-102 | 59316-0102-1059316-0102-1159316-0102-12+8 more |
| Biofreezementhol | Menthol, Unspecified form 100 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-104 | 59316-0104-1059316-0104-2059316-0104-30 |
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 |
|---|---|---|---|---|
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-099 |
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Universal Distribution Center LLC | 52000-437 |
| 1% Hydrocortisone Anti-itch | Hydrocortisone 10 mg/g | CreamTopical | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-291 |
| 10% Methyl Salicylate Pain Relief Patch10% methyl salicylate | Methyl salicylate 10 mg/100mg | TapeTopical | Akron Coating & Adhesives | 65604-222 |
| 11681168 burn spray | Lidocaine hydrochloride .02 mg/mL | SprayTopical | Dynarex Corporation | 67777-013 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-097 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Universal Distribution Center LLC | 52000-441 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-096 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Universal Distribution Center LLC | 52000-440 |
| 24 7 Relief and Recovery Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 37 mg/mL | CreamTopical | Triplicare Inc | 87656-964 |
| 2677 First Aid Burn Cream | Benzalkonium chloride 13 mg/10000mg; Lidocaine hydrochloride 50 mg/10000mg | CreamTopical | ProStat First Aid LLC | 58228-2677 |
| 2nd CHANCE MOBILITY Pain Reliefhistamine dihydrochloride | Histamine dihydrochloride .5 mg/g | CreamTopical | ALPHA NUTRITION, LLC | 83984-441 |
| 365 Medicated Lip Balmmedicated lip balm | Camphor (Natural) .0578 g/4.25g | StickTopical | Whole Foods Market, Inc. | 42681-0001 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| 4 Lidocaine Topical Anestheticlidocaine | Lidocaine 40 mg/g | CreamTopical | RUGBY LABORATORIES | 0536-1267 |
| 4% Lidocaine Maximum Strength Pain Relieflidocaine | Lidocaine .04 g/1 | PatchTopical | Shenzhen Finona Information Technology Co., Ltd | 85839-011 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-003 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-020 |
| 4% Lidocaine Patches4% lidocaine | Lidocaine 40 mg/1 | PatchTopical | Shenzhen Huayuan Hengsheng Technology Co., Ltd. | 87394-002 |
| 4% Lidocaine Patches | Lidocaine 4 g/1001 | PatchTopical | Shenzhen Chaoxiji Technology Co.,Ltd. | 87794-006 |
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