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 table| Ingredient | Strength |
|---|
| MENTHOL | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 415974, 1111683 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59316-121-10 | Biofreeze Overnight Gel | 89 mL in 1 BOTTLE | GEL | 89 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59316-121 | BIOFREEZE OVERNIGHT GEL (MENTHOL) GEL [RB HEALTH (US) LLC] | 2 | Current NDC, 1 package rows | 20241228_f5c8c08b-c7c0-f84d-e053-2a95a90add15.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 |
|---|
| 59316-121-10 | 59316012110 | 89 mL in 1 BOTTLE (59316-121-10) | 89 ml | 2023-03-01 | No | No | Current |