TopCare Nicotine
- Product NDC
- 36800-029
- 11-digit product format
- 368000029
- Labeler code
- 36800
- Product ID
- 36800-029_2a9d5005-ccae-4539-b949-e3d189cbb2a0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA076775
- Marketing category
- ANDA
- Marketing start
- 2005-04-20
- 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
- TopCare 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 | 314119 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-029-25 | TopCare Nicotine | 110 in 1 CARTON | GUM, CHEWING | 110 | | 10 |
| 36800-029-25 | TopCare Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 10 |
| 36800-029-60 | TopCare Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 10 |
| 36800-029-60 | TopCare Nicotine | 20 in 1 CARTON | GUM, CHEWING | 20 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NICOTINE | ACTIVE INGREDIENT | 6M3C89ZY6R | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| NICOTINE | ACTIVE MOIETY | 6M3C89ZY6R | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| POLACRILIN | INACTIVE INGREDIENT | RCZ785HI7S | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-029 | TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250327_beb2eddc-0fec-4f64-bceb-4e9bcee3616c.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 |
|---|
| 36800-029-25 | 36800002925 | 110 BLISTER PACK in 1 CARTON (36800-029-25) / 1 GUM, CHEWING in 1 BLISTER PACK | 110 blister pack | 2005-04-20 | 0000-00-00 | No | No | Current |
| 36800-029-60 | 36800002960 | 20 BLISTER PACK in 1 CARTON (36800-029-60) > 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2013-02-12 | 0000-00-00 | No | No | Current |