nicotine
- Product NDC
- 37808-611
- 11-digit product format
- 378080611
- Labeler code
- 37808
- Product ID
- 37808-611_52bc7f40-3a86-42dd-89d5-5a2839adf2b4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA206393
- Marketing category
- ANDA
- Marketing start
- 2023-07-31
- 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
- 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 | 311975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 37808-611-96 | nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 4 |
| 37808-611-96 | nicotine | 170 in 1 CARTON | GUM, CHEWING | 170 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-611 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [H E B] | 4 | Current NDC, 2 package rows | 20250322_55defc7f-f91d-46eb-8558-2ab1b69ec6a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 37808-611-96 | 37808061196 | 170 BLISTER PACK in 1 CARTON (37808-611-96) / 1 GUM, CHEWING in 1 BLISTER PACK | 170 blister pack | 2023-07-31 | No | No | Historical |