Over-the-counter drug · OTC MONOGRAPH DRUG
Biofreeze (Menthol) NDC 59316-870
Menthol, Unspecified form 100 mg/g · Cream · Topical · Reckitt Benckiser LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59316-870-10 | 5931608701059316087010 | 85 g in 1 JAR (59316-870-10)Marketed from Feb 15, 2024 |
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 — 100 mg/g
- Dosage form
- Cream
- 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 59316-870_51b574d1-9ee5-b2aa-e063-6294a90a5a3fSPL ID 51b574d1-9ee5-b2aa-e063-6294a90a5a3fSPL set ID 10a8face-47da-ebbe-e063-6294a90a42feRxCUI 253020, 2001133UNII 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
N459316087010followed by a unit qualifier and the quantityPackage 59316-0870-10. 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 • sprains •bruises Warnings: For external use only When using this product: ■ use only as directed ■ avoid contact with the eyes or on mucous membranes ■ do not apply to wounds or damaged skin ■ do not apply to irritated skin or if excessive irritation develops ■ do not bandage tightly or use with heating pad or device Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical …
Excerpt only. Read the full label for complete information.
About NDC 59316-870
- What is NDC 59316-870?
- 59316-870 is the product NDC for Biofreeze (menthol), Menthol, Unspecified form 100 mg/g cream, listed with the FDA by Reckitt Benckiser LLC. It has 1 package NDC, 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 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 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 |
|---|---|---|---|---|
| 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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