OPRAVA
- Product NDC
- 83538-102
- 11-digit product format
- 835380102
- Labeler code
- 83538
- Product ID
- 83538-102_0e49fac4-c067-beb0-e063-6294a90ac96f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- METHYL SALICYLATE, MENTHOL, CAPSAICIN
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Biological M.D. Solutions LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-08
- Substance
- CAPSAICIN; MENTHOL; METHYL SALICYLATE
- Active strength
- .03; 1; 10 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OPRAVA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAPSAICIN | .03 g/100mL |
| MENTHOL | 1 g/100mL |
| METHYL SALICYLATE | 10 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S07O44R1ZM, L7T10EIP3A, LAV5U5022Y |
| Rxcui | 2644111 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83538-102-18 | OPRAVA | 237 mL in 1 BOTTLE | CREAM | 237 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83538-102 | OPRAVA (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [BIOLOGICAL M.D. SOLUTIONS LLC] | 2 | Current NDC, 1 package rows | 20250202_05552560-e283-5eba-e063-6294a90a65f7.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 |
|---|
| 83538-102-18 | 83538010218 | 237 mL in 1 BOTTLE (83538-102-18) | 237 ml | 2023-08-08 | No | No | Historical |