Biofreeze Overnight Roll-on
- Product NDC
- 59316-207
- 11-digit product format
- 593160207
- Labeler code
- 59316
- Product ID
- 59316-207_51e06d5e-11fe-5814-e063-6294a90a2736
- 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
- 2023-03-16
- 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 Roll-on
- 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 |
|---|---|
| f67d7b7a-8922-73f6-e053-2995a90a2e80 | 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 |
|---|---|---|---|---|---|---|
| 59316-207-14 | Biofreeze Roll-On and Overnight Roll-On | 74 mL in 1 BOTTLE | GEL | 74 mL | 40 mg in 1mL | 5 |
| 59316-207-14 | Biofreeze Overnight Roll-on | 74 mL in 1 BOTTLE | GEL | 74 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59316-207-14 | ML - Milliliter | 59316-207 | 984f94ed-b81d-4470-a2af-d26d054baea7 | 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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Aloe Vera Cool Blue | LIDOCAINE HYDROCHLORIDE | Fruit of the Earth, Inc. | 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 | 2024-07-19 | Warnings | M017 |
| Ultra Balm | MENTHOL AND METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | de997baf-aa04-474e-b912-3fc67e720d0b | 2024-07-19 | Warnings | M017 |
| Ling Nam Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | 3f16cce3-366f-41f3-8829-6de4082a8c19 | 2024-07-19 | Warnings | M017 |
| Koong Yick Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | bc33e185-3b42-98b5-e053-2995a90a6308 | 2024-07-18 | Warnings | M017 |
| Koong Yick Hung Fa | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | 9c8a121d-6da2-4435-a2d7-a0b71d10740d | 2024-07-18 | Warnings | M017 |
| Ling Nam Hung Far | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | b6916b6e-b7eb-1eb7-e053-2995a90ae6fb | 2024-07-18 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Bionpharma Inc. | 178ed513-4f22-8f11-e063-6294a90a109b | 2024-07-16 | Warnings | M017 |
| POWERECT Benzocaine Male Delay Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a | 2024-07-16 | Warnings | M017 |
| SKINS DELAY Climax Control Benzocaine Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 53730576-2609-4f28-8bfa-a1ceea698b83 | 2024-07-16 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. | PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a0346-3b00-4803-e063-6294a90aec6d | 2024-07-13 | Warnings | M017 |
| Tidl Pain Relief Evening Therapy Spray. | PAIN RELIEF EVENING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a2f4a-7b25-e595-e063-6394a90a00d5 | 2024-07-13 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY ROLL-ON | PAIN RELIEF HEAT THERAPY ROLL-ON | Shenzhen Sam Technology Co., Ltd. | 1d0b7b8f-9e5d-00f7-e063-6394a90af87c | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY original formula Spray. | PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0b94ec-f956-dff2-e063-6294a90aca4a | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray. | PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0bf4f9-6b02-6cec-e063-6294a90a36c7 | 2024-07-12 | Warnings | M017 |
| Burn Relief | LIDOCAINE HCI 2.0% | Trifecta Pharmaceuticals USA, LLC. | e5e524cd-bb22-715f-e053-2995a90ab5d3 | 2024-07-12 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 1d10e3ca-dc93-8e1a-e063-6394a90a47c0 | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY Spray. | PAIN RELIEF HEAT THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d199826-1b27-b6e7-e063-6394a90a69ad | 2024-07-12 | Warnings | M017 |
| Tidl Pain Relief Morning Therapy Spray. | PAIN RELIEF MORNING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d19d070-3818-73de-e063-6394a90a8958 | 2024-07-12 | Warnings | M017 |
| Hydrocortisone with aloe | HYDROCORTISONE WITH ALOE ANTI ITCH | NeilMed Pharmaceuticals Inc. | 032b9f58-5f64-04dd-e063-6294a90a6bb9 | 2024-07-10 | Warnings | M017 |
| Octagon Pain Relief | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 9926f733-1506-4224-9d70-b1813cd81ec3 | 2024-07-08 | Warnings | M017 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59316-207-14 | 59316020714 | 74 mL in 1 BOTTLE (59316-207-14) | 74 ml | 2023-03-16 | No | No | Current |