NICOTINE
- Product NDC
- 58602-854
- 11-digit product format
- 586020854
- Labeler code
- 58602
- Product ID
- 58602-854_1c1decb8-46f9-47ef-8964-e37d233fc36c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX MINI
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA215357
- Marketing category
- ANDA
- Marketing start
- 2022-05-13
- 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
- NICOTINE
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58602-854-81 | NICOTINE | 4 in 1 CARTON | LOZENGE | 4 | | 3 |
| 58602-854-83 | NICOTINE | 27 in 1 CONTAINER | LOZENGE | 27 | | 3 |
| 58602-854-84 | NICOTINE | 3 in 1 CARTON | LOZENGE | 3 | | 3 |
| 58602-854-85 | NICOTINE | 5 in 1 CARTON | LOZENGE | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58602-854 | NICOTINE (NICOTINE POLACRILEX MINI) LOZENGE [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250515_5102e242-4d27-4b1f-8a65-2b52ba3f2276.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 |
|---|
| 58602-854-81 | 58602085481 | 4 CONTAINER in 1 CARTON (58602-854-81) / 27 LOZENGE in 1 CONTAINER (58602-854-83) | 4 container | 2022-05-13 | 0000-00-00 | No | No | Current |
| 58602-854-83 | 58602085483 | 27 in 1 CONTAINER | | | | | | Historical |
| 58602-854-84 | 58602085484 | 3 CONTAINER in 1 CARTON (58602-854-84) / 27 LOZENGE in 1 CONTAINER (58602-854-83) | 3 container | 2022-05-13 | 0000-00-00 | No | No | Current |
| 58602-854-85 | 58602085485 | 5 CONTAINER in 1 CARTON (58602-854-85) / 27 LOZENGE in 1 CONTAINER (58602-854-83) | 5 container | 2022-05-13 | 0000-00-00 | No | No | Current |