Over-the-counter drug · OTC MONOGRAPH DRUG
Biofreeze (Menthol) NDC 59316-101
Menthol, Unspecified form 35 mg/mL · Gel · Topical · Reckitt Benckiser LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)59316-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59316-0101Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59316-101-10 | 5931601011059316010110 | 5 mL in 1 PACKET (59316-101-10)Marketed from Aug 25, 2016 | |
| 59316-101-11 | 5931601011159316010111 | 30 mL in 1 BOTTLE (59316-101-11)Marketed from Aug 25, 2016 | |
| 59316-101-12 | 5931601011259316010112 | 59 mL in 1 TUBE (59316-101-12)Marketed from Aug 25, 2016 | |
| 59316-101-13 | 5931601011359316010113 | 59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)Marketed from Aug 25, 2016 | |
| 59316-101-15 | 5931601011559316010115 | 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15)Marketed from Aug 25, 2016 | |
| 59316-101-19 | 5931601011959316010119 | 3 mL in 1 PACKET (59316-101-19)Marketed from Jan 1, 2022 | |
| 59316-101-20 | 5931601012059316010120 | 118 mL in 1 TUBE (59316-101-20)Marketed from Aug 25, 2016 | |
| 59316-101-30 | 5931601013059316010130 | 473 mL in 1 BOTTLE, PUMP (59316-101-30)Marketed from Aug 25, 2016 | |
| 59316-101-40 | 5931601014059316010140 | 946 mL in 1 BOTTLE, PUMP (59316-101-40)Marketed from Aug 25, 2016 | |
| 59316-101-50 | 5931601015059316010150 | 3785 mL in 1 BOTTLE, PUMP (59316-101-50)Marketed from Aug 25, 2016 |
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, Unspecified form — 35 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 59316-101_51b434c9-228b-2c05-e063-6394a90a1e94SPL ID 51b434c9-228b-2c05-e063-6394a90a1e94SPL set ID 684faf63-5e44-4471-8384-e8fa7c0d842aRxCUI 808955, 1043451UNII 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
N459316010110followed by a unit qualifier and the quantityPackage 59316-0101-10. 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 - sprain
Excerpt only. Read the full label for complete information.
About NDC 59316-101
- What is NDC 59316-101?
- 59316-101 is the product NDC for Biofreeze (menthol), Menthol, Unspecified form 35 mg/mL gel, listed with the FDA by Reckitt Benckiser LLC. It has 10 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, 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?
- 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 105 mg/mL | SprayTopical | Reckitt Benckiser LLC | 59316-833 | 59316-0833-1059316-0833-20 |
| Biofreezementhol | Menthol, Unspecified form 100 mg/g | CreamTopical | Reckitt Benckiser LLC | 59316-869 | 59316-0869-10 |
| 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 |
|---|---|---|---|---|
| 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 |
Showing 20 of 40.