Biofreeze
- Product NDC
- 59316-833
- 11-digit product format
- 593160833
- Labeler code
- 59316
- Product ID
- 59316-833_51b57ded-2d7c-d540-e063-6394a90a4744
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- MENTHOL
- Active strength
- 105 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | 105 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 1489073, 1489074 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59316-833-10 | Biofreeze | 89 mL in 1 BOTTLE | SPRAY | 89 | | 12 |
| 59316-833-20 | Biofreeze | 118 mL in 1 BOTTLE | SPRAY | 118 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59316-833 | BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC] | 10 | Current NDC, 2 package rows | 20240202_00bb462a-27d0-6f74-e063-6394a90a90ec.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 |
|---|
| 59316-833-10 | 59316083310 | 89 mL in 1 BOTTLE (59316-833-10) | 89 ml | 2023-12-01 | No | No | Current |
| 59316-833-20 | 59316083320 | 118 mL in 1 BOTTLE (59316-833-20) | 118 ml | 2026-01-01 | No | No | Current |