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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biofreeze Overnight Roll-on
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 415974, 1111683 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59316-207 | BIOFREEZE OVERNIGHT ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC] | 2 | Current NDC, 1 package rows | 20241228_f67d7b7a-8922-73f6-e053-2995a90a2e80.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |