Nicotine Mini
- Product NDC
- 0536-1239
- 11-digit product format
- 005361239
- Labeler code
- 0536
- Product ID
- 0536-1239_4eae8948-a3c6-4ca1-8c88-0ab5ac393532
- 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
- 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 Mini
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1239-27 | Nicotine Mini | 1 in 1 BOX | LOZENGE | 1 | | 8 |
| 0536-1239-27 | Nicotine Mini | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 8 |
| 0536-1239-81 | Nicotine Mini | 3 in 1 BOX | LOZENGE | 3 | | 8 |
| 0536-1239-81 | Nicotine Mini | 27 in 1 BOTTLE, PLASTIC | LOZENGE | 27 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1239 | NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [RUGBY LABORATORIES, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250105_be17cbe9-43bb-424e-9d91-fba4f02691bb.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 |
|---|
| 0536-1239-27 | 00536123927 | 1 BOTTLE, PLASTIC in 1 BOX (0536-1239-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-07-31 | | No | No | Current |
| 0536-1239-81 | 00536123981 | 3 BOTTLE, PLASTIC in 1 BOX (0536-1239-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-07-31 | 0000-00-00 | No | No | Current |