Biofreeze
- Product NDC
- 59316-104
- 11-digit product format
- 593160104
- Labeler code
- 59316
- Product ID
- 59316-104_51b427be-af9f-1fbe-e063-6394a90acada
- 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
- 2010-11-01
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 100 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, UNSPECIFIED FORM | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 667889, 1043232 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59316-104-10 | Biofreeze | 59 mL in 1 BOTTLE, SPRAY | SPRAY | 59 | | 40 |
| 59316-104-20 | Biofreeze | 118 mL in 1 BOTTLE, SPRAY | SPRAY | 118 | | 40 |
| 59316-104-25 | Biofreeze | 118 mL in 1 BOTTLE, SPRAY | SPRAY | 118 | | 40 |
| 59316-104-30 | Biofreeze | 473 mL in 1 BOTTLE, SPRAY | SPRAY | 473 | | 40 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59316-104 | BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC] | 38 | Current NDC, Legacy NDC, 4 package rows | 20240110_5edddb99-6596-4a3b-b361-1cc04d032c31.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59316-104-10 | 59316010410 | 59 mL in 1 BOTTLE, SPRAY (59316-104-10) | 59 ml | 2016-08-25 | 0000-00-00 | No | No | Current |
| 59316-104-20 | 59316010420 | 118 mL in 1 BOTTLE, SPRAY (59316-104-20) | 118 ml | 2016-08-25 | 0000-00-00 | No | No | Current |
| 59316-104-25 | 59316010425 | 118 mL in 1 BOTTLE, SPRAY | 118 ml | | | | | Historical |
| 59316-104-30 | 59316010430 | 473 mL in 1 BOTTLE, SPRAY (59316-104-30) | 473 ml | 2016-08-25 | 0000-00-00 | No | No | Current |