Nicorette
- Product NDC
- 0135-8050
- 11-digit product format
- 001358050
- Labeler code
- 0135
- Product ID
- 0135-8050_52061944-15dc-452a-8135-57033cc601ad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA022360
- Marketing category
- NDA
- Marketing start
- 2025-09-01
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicorette
- Brand name suffix
- Peppermint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359817, 359818, 968849, 968851 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-8050-20 | NicorettePeppermint | 1 in 1 PACKAGE | LOZENGE | 1 | | 2 |
| 0135-8050-20 | NicorettePeppermint | 20 in 1 VIAL | LOZENGE | 20 | | 2 |
| 0135-8050-81 | NicorettePeppermint | 3 in 1 PACKAGE | LOZENGE | 3 | | 2 |
| 0135-8050-81 | NicorettePeppermint | 27 in 1 VIAL | LOZENGE | 27 | | 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 |
|---|
| 0135-8050-20 | 00135805020 | 1 VIAL in 1 PACKAGE (0135-8050-20) / 20 LOZENGE in 1 VIAL | 1 vial | 2025-09-01 | No | No | Historical |
| 0135-8050-81 | 00135805081 | 3 VIAL in 1 PACKAGE (0135-8050-81) / 27 LOZENGE in 1 VIAL | 3 vial | 2025-09-01 | No | No | Historical |