NICOTINE
- Product NDC
- 17856-0722
- 11-digit product format
- 178560722
- Labeler code
- 17856
- Product ID
- 17856-0722_5d579f42-4397-1913-e063-6294a90aff7f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX MINI
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp
- Application
- ANDA215357
- Marketing category
- ANDA
- Marketing start
- 2022-11-03
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 17856-0722 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 17856-0722 | 17856-0722-7 | D | Discontinued by firm | 2026-10-12 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215357-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | ||
| A215357-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 5c6f7cd8ea54… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215357-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215357-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2022-05-13 | ea1830bbd6c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NICOTINE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 2 mg/1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | 5102e242-4d27-4b1f-8a65-2b52ba3f2276 | 2025-05-14 | Warnings | 215357 ANDA215357 |
| AMAZON BASIC CARE NICOTINE POLACRILEX | NICOTINE POLACRILEX MINI | Amazon.com Services LLC | 113e54e3-e9c3-4949-e063-6394a90a6fdf | 2025-05-02 | Warnings | 215357 ANDA215357 |
| AMAZON BASIC CARE NICOTINE POLACRILEX | NICOTINE POLACRILEX MINI | Amazon.com Services LLC | 10ee6816-8155-d590-e063-6394a90a9dea | 2025-05-02 | Warnings | 215357 ANDA215357 |
| NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | 169c7976-f865-4716-953d-383e435d67c5 | 2024-06-20 | Warnings | 215357 ANDA215357 |
| NICOTINE | NICOTINE POLACRILEX MINI | BLIP PRODUCTS, INC. | e88c8815-4d38-3a59-e053-2995a90afc82 | 2023-08-11 | Warnings | 215357 ANDA215357 |
| NICOTINE | NICOTINE POLACRILEX MINI | BLIP PRODUCTS, INC. | eb714022-332d-5c6f-e053-2a95a90a75c9 | 2023-08-11 | Warnings | 215357 ANDA215357 |
| NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | 85f05cc6-ae2e-4338-8c1e-c681c2f90858 | 2022-11-03 | Warnings | 215357 ANDA215357 |
| NICOTINE | NICOTINE POLACRILEX MINI | Aurohealth LLC | cfe6fb63-2897-4e76-8288-1389f363b3c4 | 2022-11-03 | Warnings | 215357 ANDA215357 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-0722-4 | 17856072204 | 44 POUCH in 1 BOX, UNIT-DOSE (17856-0722-4) / 1 LOZENGE in 1 POUCH | 44 pouch | 2026-10-05 | No | No | Current |