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
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 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 |
|---|---|---|---|---|---|---|
| Up up | PAIN RELIEF ADVANCED HYDROGEL PATCHES | Target Corporation | 44128b70-3172-ee37-e063-6294a90a705f | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | f03090fa-f7e6-f53a-e053-2a95a90aa819 | 2025-11-20 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | ff073e47-3107-e17e-e053-6294a90a58fa | 2025-11-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET NOVELTIES, INC | fc8a8f20-97ab-481e-e053-6394a90a3525 | 2025-11-20 | Warnings | M017 |
| MENTHOL | MENTHOL | SUNSET PAIN RELIEF ROLL-ON 3OZ | 934d4638-b47b-187d-e053-2995a90ae69d | 2025-11-20 | Warnings | M017 |
| FOOT PAIN RELIEF ROLL-ON | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 43edcea0-ab04-f368-e063-6294a90a817a | 2025-11-19 | Warnings | M017 |
| Absolut Skin Corticosoothe Anti-Itch | HYDROCORTISONE | Absolut Skin Incorporated | deb52218-9176-4aaa-a22f-b66dada6690f | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy | LIDOCAINE | InterMed Laboratories Private Limited | 43f3d189-f6b7-02ed-e063-6394a90afd73 | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch HealthA2Z | LIDOCAINE | InterMed Laboratories Private Limited | 43f3e288-e828-8130-e063-6394a90a6d44 | 2025-11-19 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch Leader | LIDOCAINE | InterMed Laboratories Private Limited | 42f06914-c8b8-ea9c-e063-6294a90a79e6 | 2025-11-19 | Warnings | M017 |
| CVS Anti-Itch | CAMPHOR, MENTHOL | CVS | 87715662-c788-9a8d-e053-2a95a90acb53 | 2025-11-19 | Warnings | M017 |
| Walgreen Anti Itch | CAMPHOR, MENTHOL | Walgreens | b4f47a8d-d4a6-9233-e053-2a95a90afd90 | 2025-11-19 | Warnings | M017 |
| Leader Anti-Itch | CAMPHOR, MENTHOL | LEADER/Cardinal Helath 110, Inc. | 9ca985c6-5017-0558-e053-2995a90a8202 | 2025-11-19 | Warnings | M017 |
| CVS Anti-Itch | PRAMOXINE HCL | CVS | 87fc476a-5b12-7383-e053-2995a90a530b | 2025-11-19 | Warnings | M017 |
| Walgreen Anti-Itch | PRAMOXINE HCL | Walgreens | b5f9d1c5-891e-4377-e053-2995a90aa281 | 2025-11-19 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 89f5f688-856f-f2df-e053-2995a90a73cf | 2025-11-19 | Warnings | M017 |
| Itch Eraser | DIPHENHYDRAMINE HCL | Tender Corporation d/b/a Adventure Ready Brands | 2204e135-6a23-68a2-e063-6394a90ac019 | 2025-11-18 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | c8594e10-661f-6ff3-e053-2995a90ab4fc | 2025-11-18 | Warnings | M017 |
| Mag 5 PT Cooling Formula Recovery Cream | MENTHOL | RENU LABORATORIES, LLC | a45cde67-64ec-643b-e053-2a95a90a10b6 | 2025-11-18 | Warnings | M017 |
| After Ivy Wipe | CAMPHOR | Tender Corporation d/b/a Adventure Ready Brands | 21d98018-826a-1d0d-e063-6294a90a0a71 | 2025-11-17 | 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 |