Biofreeze Professional Roll-On
- Product NDC
- 59316-117
- 11-digit product format
- 593160117
- Labeler code
- 59316
- Product ID
- 59316-117_51e09cee-5dd5-65f6-e063-6394a90a2c67
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-06-03
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 50 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biofreeze Professional Roll-On
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 50 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f62f8ec3-593d-480a-85a0-01fcd7f1790c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-117-10 | Biofreeze Professional Roll-On | 89 mL in 1 BOTTLE | GEL | 89 | 10 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EjaGuard | LIDOCAINE | MOLANSPACE INC | 475f64ef-d636-7e87-e063-6294a90ae32f | 2026-03-25 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | ProStat First Aid | 4e53d29c-ed3c-f481-e063-6294a90a3181 | 2026-03-25 | Warnings | M017 |
| Topicaine Ultra | TOPICAINE ULTRA | Oncora Pharma, LLC | e052f718-700a-44e0-8770-65451b812ee1 | 2026-03-24 | Warnings | M017 |
| Hot Pap Cataplasma | METHYL SALICYLATE, VANILLYL NONYLAMIDE | Masaem Company | 4dbeda13-b198-0cf0-e063-6294a90a8180 | 2026-03-24 | Warnings | M017 |
| Barmicil Anti-itch | HYDROCORTISONE | OPMX LLC | 850084c3-1dd4-eb8d-e053-2a91aa0a130b | 2026-03-24 | Warnings | M017 |
| Jeil Hangbang Paff Soo S Cataplasma | GLYCOL SALICYLATE, L-MENTHOL | Masaem Company | 4dd040db-07cf-361a-e063-6394a90a8001 | 2026-03-24 | Warnings | M017 |
| Zenol Double Action | METHYL SALICYLATE, L-MENTHOL | BA TRADE INC | 4da998fc-75a3-583f-e063-6394a90a59c7 | 2026-03-23 | Warnings | M017 |
| Ultra Strength Topical Pain Relief Cream | CAMPHOR, MENTHOL, METHYL SALICYLATE | J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD | 4db9ae57-4ab4-8fe4-e063-6394a90a7e51 | 2026-03-23 | Warnings | M017 |
| DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON | ALIVIO TOTAL ROLL ON | EVI LABS | 4da01338-8739-08a8-e063-6294a90ae157 | 2026-03-22 | Warnings | M017 |
| DR SANA ALIVIO TOTAL ALIVIO TOTAL | ALIVIO TOTAL | EVI LABS | 4da1c3b8-9af2-6e9f-e063-6394a90a86ae | 2026-03-22 | Warnings | M017 |
| SORE NO MORE | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | 80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd | 2026-03-20 | Warnings | M017 |
| CVS Health Antiseptic Wound Wash | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | CVS Pharmacy | 53ac017a-eccb-3b24-e054-00144ff88e88 | 2026-03-20 | Warnings | M017 |
| Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2% | ANTI ITCH GEL | Walgreens | 3d6e8c62-2fcc-51c2-e063-6394a90a33f7 | 2026-03-20 | Warnings | M017 |
| ANIXIKE Numbing | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d5c52d7-8e81-b62f-e063-6394a90ad03e | 2026-03-19 | Warnings | M017 |
| SYLVIRENE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d47e8c7-d293-bf63-e063-6294a90a5fd9 | 2026-03-18 | Warnings | M017 |
| Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | f7aa9330-c47c-4d2f-b784-11b831d919d6 | 2026-03-18 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 99726aa3-3b45-4175-8471-279419af5457 | 2026-03-18 | Warnings | M017 |
| Dr.Harry COMFORT ZONE Cream | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAM | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d32b89f-72e8-bc93-e063-6394a90a0bc8 | 2026-03-17 | Warnings | M017 |
| MiloRod Ultra Muscle Rub Fast-Acting Pain Relief | CAPSAICIN, MENTHOL | Milo Rod Import & Export, Inc. | c3622dc3-0c05-47c9-b70b-498946781906 | 2026-03-17 | Warnings | M017 |
| Walgreens Burn Pad | BURN PAD | Walgreens | 3f8d7624-cf1e-1992-e063-6294a90a3806 | 2026-03-17 | Boxed warning, Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1794892 | BIOFREEZE 5 % Topical Gel | PSN | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
| 415975 | menthol 5 % Topical Gel | PSN | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
| 1794892 | menthol 0.05 MG/MG Topical Gel [Biofreeze] | SBD | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
| 415975 | menthol 0.05 MG/MG Topical Gel | SCD | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
| 1794892 | Biofreeze 5 % Topical Gel | SY | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
| 415975 | menthol 5 % Topical Gel | SY | f62f8ec3-593d-480a-85a0-01fcd7f1790c | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59316-117-10 | 59316011710 | 89 mL in 1 BOTTLE (59316-117-10) | 89 ml | 2016-06-03 | 0000-00-00 | No | No | Current |