Biofreeze Roll-On and Overnight Roll-On
- Product NDC
- 59316-209
- 11-digit product format
- 593160209
- Labeler code
- 59316
- Product ID
- 59316-209_51e076b8-984a-b24a-e063-6294a90ae9c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- KIT
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-01
- 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 Roll-On and Overnight Roll-On
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-205-14 | Biofreeze Roll-On and Overnight Roll-On | 74 mL in 1 BOTTLE | GEL | 74 mL | 40 mg in 1mL | 5 |
| 59316-207-14 | Biofreeze Roll-On and Overnight Roll-On | 74 mL in 1 BOTTLE | GEL | 74 mL | 40 mg in 1mL | 5 |
| 59316-209-14 | Biofreeze Roll-On and Overnight Roll-On | 1 in 1 BOTTLE | KIT | 1 | 5 | |
| 59316-209-14 | Biofreeze Roll-On and Overnight Roll-On | 2 in 1 KIT | KIT | 2 | 5 |
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 |
|---|---|---|---|---|---|---|
| Good Neighbor Roll-on Menthol Pain Relief Gel | MENTHOL | Amerisource Bergen | bd557323-0003-4ee6-b22d-a72d621c7de4 | 2025-08-05 | Warnings | M017 |
| Earthmed FS Pain relieving balm | MENTHOL | Earthmed LLC | 3ba4e769-fec6-52d9-e063-6394a90a65d4 | 2025-08-05 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | HF Acquisition Co LLC, DBA HealthFirst | 3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6 | 2025-08-05 | Warnings | M017 |
| Kocowo Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 3b82989d-7cc3-23d3-e063-6294a90ae2a3 | 2025-08-03 | Warnings | M017 |
| Menthol pain relief patches | MENTHOL | Menthol pain relief patch | 3b5fd718-3f86-f7a7-e063-6294a90a8c52 | 2025-08-02 | Warnings | M017 |
| Graphene Far Infrared Herbal Pain Relief Patches | CORYDALIS RHIZOME | Changsha Maocheng Trading Co., Ltd | 3b604a3c-fe91-7096-e063-6394a90afe04 | 2025-08-02 | Warnings | M017 |
| Active Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3a9f9ca0-3d8a-796a-e063-6394a90a790c | 2025-08-01 | Warnings | M017 |
| Active Recovery Pain Relief Stick | CAMPHOR, MENTHOL | Charlottes Web, Inc. | 3aa037c6-6109-b52e-e063-6394a90a215b | 2025-08-01 | Warnings | M017 |
| PM Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3aa08859-809d-de8c-e063-6394a90a8e25 | 2025-08-01 | Warnings | M017 |
| Wish ultra winter ice | MENTHOL | LJ Pharma | b4c5487c-1314-4d63-96df-077e72e7ee95 | 2025-08-01 | Warnings | M017 |
| Rugged Fit Pain Relief Roll On | MENTHOL, METHYL SALICYLATE | SYSTEM4BOOK LLC | 39d68734-981c-14d7-e063-6294a90a4919 | 2025-08-01 | Warnings | M017 |
| ICY FREEZE | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 28fdb049-b297-4358-9447-7d69ba879702 | 2025-08-01 | Warnings | M017 |
| Cortizone 10 Cooling | HYDROCORTISONE | Chattem, Inc. | 14d9fce2-9f54-4204-83cb-161de8a303f0 | 2025-08-01 | Warnings | M017 |
| Bravado Labs Numbing | LIDOCAINE HCL | Prodigy Media Inc | 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 | 2025-07-30 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3721c984-1993-6265-e063-6394a90af23f | 2025-07-29 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3758d625-010f-7441-e063-6394a90a066d | 2025-07-29 | Warnings | M017 |
| Cold Therapy Roll on | COLD THERAPY ROLL ON | Allegiant Health | 36463acb-7c28-416f-a45f-a93f0be5692b | 2025-07-29 | Warnings | M017 |
| ProCure Anti Itch | CAMPHOR 0.5% | Twin Med LLC | 3afe387c-ef42-215d-e063-6394a90a41b5 | 2025-07-28 | Warnings | M017 |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | M017 |
| SYNC ICE | SYNC RELIEF ICE | iON Pharma, LLC | 38ce98ce-a7bf-8041-e063-6394a90ae730 | 2025-07-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111683 | BIOFREEZE 4 % Topical Gel | PSN | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 4 % Topical Gel | PSN | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | menthol 0.04 MG/MG Topical Gel [Biofreeze] | SBD | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | Biofreeze 0.04 MG/MG Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 1111683 | Biofreeze 4 % Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
| 415974 | menthol 4 % Topical Gel | SY | 4d3dcb8f-2075-6bbc-e063-6394a90a4992 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59316-205-14 | 59316020514 | 74 mL in 1 BOTTLE | 74 ml | Historical | |||
| 59316-207-14 | 59316020714 | 74 mL in 1 BOTTLE | 74 ml | Historical | |||
| 59316-209-14 | 59316020914 | 2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) | 2 bottle | 2026-04-01 | No | No | Current |