Monistat 3
- Product NDC
- 63736-015
- 11-digit product format
- 637360015
- Labeler code
- 63736
- Product ID
- 63736-015_09cb5f1c-b40a-426f-94d0-ec18662feb0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Insight Pharmaceuticals LLC
- Application
- NDA020827
- Marketing category
- NDA
- Marketing start
- 1998-03-30
- Substance
- MICONAZOLE NITRATE
- Active strength
- 40 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Monistat 3
- Brand name suffix
- 3 Day
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MICONAZOLE NITRATE | 40 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VW4H1CYW1K |
| Rxcui | 998544, 998546 |
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 |
|---|
| 63736-015-18 | Monistat 33 Day | 3 in 1 CARTON | CREAM | 3 | | 7 |
| 63736-015-18 | Monistat 33 Day | 5 g in 1 TUBE, WITH APPLICATOR | CREAM | 5 | | 7 |
| 63736-015-25 | Monistat 33 Day | 1 in 1 CARTON | CREAM | 1 | | 7 |
| 63736-015-25 | Monistat 33 Day | 25 g in 1 TUBE, WITH APPLICATOR | CREAM | 25 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63736-015 | MONISTAT 3 3 DAY (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241109_f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63736-015-18 | 63736001518 | 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR | 1998-03-30 | 0000-00-00 | No | No | Current |
| 63736-015-25 | 63736001525 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR | 1998-03-30 | | No | No | Historical |