DentiCalm
- Product NDC
- 82765-0002
- 11-digit product format
- 827650002
- Labeler code
- 82765
- Product ID
- 82765-0002_414fc815-5882-86b6-e063-6294a90ad818
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Topical Analgesic
- Dosage form
- EMULSION
- Route
- TOPICAL
- Labeler
- NFUSE LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- MENTHOL
- Active strength
- 2 g/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DentiCalm
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | 2 g/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 1146695 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82765-0002-0 | DentiCalm | 1 in 1 PACKAGE | EMULSION | 1 | | 2 |
| 82765-0002-1 | DentiCalm | 0.47 mL in 1 APPLICATOR | EMULSION | 0.47 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82765-0002-0 | 82765000200 | 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1) | 1 applicator | 2024-02-01 | No | No | Historical |
| 82765-0002-1 | 82765000201 | 0.47 mL in 1 APPLICATOR | 0.47 ml | | | | Historical |