NICOTINE Oral Pouch
- Product NDC
- 87494-001
- 11-digit product format
- 874940001
- Labeler code
- 87494
- Product ID
- 87494-001_5032e3c6-1153-d550-e063-6294a90a42a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Guangzhou Shuimu Jiahe Trading Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-08
- Substance
- NICOTINE
- Active strength
- 8 mg/1000mg
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NICOTINE Oral Pouch
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 8 mg/1000mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87494-001-01 | NICOTINE Oral Pouch | 45 mg in 1 BOX, UNIT-DOSE | LOZENGE | 45 | | 2 |
| 87494-001-02 | NICOTINE Oral Pouch | 3 in 1 BOX | LOZENGE | 3 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87494-001-01 | 87494000101 | 45 mg in 1 BOX, UNIT-DOSE | 45 mg | | | | Historical |
| 87494-001-02 | 87494000102 | 3 BOX, UNIT-DOSE in 1 BOX (87494-001-02) / 45 mg in 1 BOX, UNIT-DOSE (87494-001-01) | | 2026-03-08 | No | No | Current |