Biofreeze Ultraflex
- Product NDC
- 59316-899
- 11-digit product format
- 593160899
- Labeler code
- 59316
- Product ID
- 59316-899_30dfaa6b-e80e-20a0-e063-6294a90a200b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine
- Dosage form
- PATCH
- Route
- TOPICAL
- Labeler
- RB Health (US) LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-15
- Substance
- LIDOCAINE
- Active strength
- .04 g/g
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Biofreeze Ultraflex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | .04 g/g |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59316-899-04 | Biofreeze Ultraflex | 4 in 1 CARTON | PATCH | 4 | | 4 |
| 59316-899-04 | Biofreeze Ultraflex | 2 g in 1 PATCH | PATCH | 2 | | 4 |
| 59316-899-07 | Biofreeze Ultraflex | 2 g in 1 PATCH | PATCH | 2 | | 4 |
| 59316-899-07 | Biofreeze Ultraflex | 1 in 1 POUCH | PATCH | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59316-899 | BIOFREEZE ULTRAFLEX (LIDOCAINE) PATCH [RB HEALTH (US) LLC] | 3 | Current NDC, 4 package rows | 20250323_2655974b-a67d-9f07-e063-6294a90a54e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59316-899-04 | 59316089904 | 4 PATCH in 1 CARTON (59316-899-04) / 2 g in 1 PATCH | 4 patch | 2025-01-15 | No | No | Current |
| 59316-899-07 | 59316089907 | 1 PATCH in 1 POUCH (59316-899-07) / 2 g in 1 PATCH | 1 patch | 2025-01-15 | No | No | Current |