OsmoFlex
- Product NDC
- 67676-101
- 11-digit product format
- 676760101
- Labeler code
- 67676
- Product ID
- 67676-101_08b4632c-2421-6046-e063-6294a90a1527
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sarati International, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-05-16
- Substance
- MENTHOL
- Active strength
- 1.3 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
- OsmoFlex
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | 1.3 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 436147, 1050947 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67676-101-01 | OsmoFlex | 113.4 g in 1 TUBE | CREAM | 113.4 | | 7 |
| 67676-101-03 | OsmoFlex | 964.3 g in 1 BOTTLE | CREAM | 964.3 | | 7 |
| 67676-101-04 | OsmoFlex | 453.6 g in 1 BOTTLE | CREAM | 453.6 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67676-101 | OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20231102_479147c0-4cf4-4d7a-8b8e-1a0de49ed73e.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 |
|---|
| 67676-101-01 | 67676010101 | 113.4 g in 1 TUBE (67676-101-01) | 113.4 g | 2016-05-16 | 0000-00-00 | No | No | Current |
| 67676-101-03 | 67676010103 | 964.3 g in 1 BOTTLE (67676-101-03) | 964.3 g | 2016-05-16 | 0000-00-00 | No | No | Current |
| 67676-101-04 | 67676010104 | 453.6 g in 1 BOTTLE (67676-101-04) | 453.6 g | 2016-05-16 | 0000-00-00 | No | No | Current |