Mini Nicotine
- Product NDC
- 0536-1241
- 11-digit product format
- 005361241
- Labeler code
- 0536
- Product ID
- 0536-1241_a7edbfeb-3193-4578-891b-b2b77a6340ad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Rugby Laboratories, Inc.
- Application
- ANDA207868
- Marketing category
- ANDA
- Marketing start
- 2019-07-31
- Substance
- NICOTINE
- Active strength
- 4 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
- Mini Nicotine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 359818 |
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 |
|---|
| 0536-1241-27 | Mini Nicotine | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 9 |
| 0536-1241-27 | Mini Nicotine | 1 in 1 BOX | LOZENGE | 1 | | 9 |
| 0536-1241-81 | Mini Nicotine | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 9 |
| 0536-1241-81 | Mini Nicotine | 3 in 1 BOX | LOZENGE | 3 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1241 | MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [RUGBY LABORATORIES, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250109_237471f8-ce0f-423b-993f-b4380fd890ff.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 |
|---|
| 0536-1241-27 | 00536124127 | 1 BOTTLE, PLASTIC in 1 BOX (0536-1241-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-07-31 | | No | No | Current |
| 0536-1241-81 | 00536124181 | 3 BOTTLE, PLASTIC in 1 BOX (0536-1241-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-07-31 | 0000-00-00 | No | No | Current |