FLANAX
- Product NDC
- 27854-499
- 11-digit product format
- 278540499
- Labeler code
- 27854
- Product ID
- 27854-499_1cadd0fb-dd05-4b32-ae8e-c3e3d73137db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Methyl Salicylate, Menthol, Capsaicin
- Dosage form
- LINIMENT
- Route
- TOPICAL
- Labeler
- Belmora LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-01
- Substance
- CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
- Active strength
- .003; 10; 28 g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLANAX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAPSAICIN | .003 g/100g |
| MENTHOL, UNSPECIFIED FORM | 10 g/100g |
| METHYL SALICYLATE | 28 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S07O44R1ZM, L7T10EIP3A, LAV5U5022Y |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27854-499-01 | FLANAX | 1 in 1 CARTON | LINIMENT | 1 | | 1 |
| 27854-499-01 | FLANAX | 28.35 g in 1 TUBE | LINIMENT | 28.35 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27854-499 | FLANAX (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LINIMENT [BELMORA LLC] | 1 | Current NDC, 2 package rows | 20241212_5e06c688-a086-4c1c-8dab-fcead61fef40.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 27854-499-01 | 27854049901 | 1 TUBE in 1 CARTON (27854-499-01) / 28.35 g in 1 TUBE | 1 tube | 2024-08-01 | No | No | Current |