Biofreeze Overnight Gel
- Product NDC
- 59316-121
- 11-digit product format
- 593160121
- Labeler code
- 59316
- Product ID
- 59316-121_51e06548-d75f-53d6-e063-6294a90a66eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-03-01
- Substance
- MENTHOL
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biofreeze Overnight Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f5c8c08b-c7c0-f84d-e053-2a95a90add15 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59316-121-10 | Biofreeze Overnight Gel | 89 mL in 1 BOTTLE | GEL | 89 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59316-121-10 | ML - Milliliter | 59316-121 | 7f28a9d8-6572-47d0-b64b-d01bd794e6cd | 1 | 2024-02-14 |
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 |
|---|---|---|---|---|---|---|
| Inknows Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 59eb9c12-9e00-0171-e063-6394a90a8342 | 2026-08-25 | Warnings | M017 |
| Lidomar | LIDOMAR | Oncora Pharma, LLC | 215bfdca-60bf-480b-b02e-902de52fe5e8 | 2026-08-25 | Warnings | M017 |
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c7e13f-b9ea-023a-e063-6294a90a79e0 | 2026-08-24 | Warnings | M017 |
| KNEE PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c8b33a-7d4f-2c6e-e063-6394a90a7929 | 2026-08-24 | Warnings | M017 |
| Bovonte Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5958cc29-c449-56a7-e063-6394a90a960b | 2026-08-24 | Warnings | M017 |
| JELVOXA NECK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a3d60a-26b5-e6a6-e063-6294a90a42bd | 2026-08-22 | Warnings | M017 |
| JELVOXA DMSO | CAMPHOR CAPSAICIN MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a43e2c-d258-34b5-e063-6394a90a09bf | 2026-08-22 | Warnings | M017 |
| Capsaicin 0.035 Percent | CAPSAICIN | Preferred Pharmaceuticals Inc. | 0fabc025-4208-45f5-b3c2-543ae3a2df41 | 2026-08-21 | Warnings | M017 |
| Claravie | HYDROCORTISONE ACETATE | Gentell LLC | 598d224b-d12e-89bf-e063-6394a90a84dc | 2026-08-21 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 3b8c2419-7a78-2731-e054-00144ff8d46c | 2026-08-21 | Warnings | M017 |
| Enokon Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 5976e667-e506-1d11-e063-6394a90a6809 | 2026-08-20 | Warnings | M017 |
| MQUPIN TIGER Patch | TIGER PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5977cbb5-94c7-cb24-e063-6294a90a2e07 | 2026-08-20 | Warnings | M017 |
| MQUPIN Nicotine Patches | NICOTINE PATCHES | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5978258a-549e-50e6-e063-6394a90a3d86 | 2026-08-20 | Warnings | M017 |
| Claravie | CAMPHOR | Gentell LLC | 5978bdab-5359-be9a-e063-6394a90a5a32 | 2026-08-20 | Warnings | M017 |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | M017 |
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1111683 | BIOFREEZE 4 % Topical Gel | PSN | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 415974 | menthol 4 % Topical Gel | PSN | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 1111683 | menthol 0.04 MG/MG Topical Gel [Biofreeze] | SBD | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 1111683 | Biofreeze 0.04 MG/MG Topical Gel | SY | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 1111683 | Biofreeze 4 % Topical Gel | SY | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
| 415974 | menthol 4 % Topical Gel | SY | f5c8c08b-c7c0-f84d-e053-2a95a90add15 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59316-121-10 | 59316012110 | 89 mL in 1 BOTTLE (59316-121-10) | 89 ml | 2023-03-01 | No | No | Current |