NICOTINE
- Product NDC
- 17856-0906
- 11-digit product format
- 178560906
- Labeler code
- 17856
- Product ID
- 17856-0906_5d19b024-f037-96b7-e063-6294a90a9806
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NICOTINE POLACRILEX
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp.
- Application
- ANDA213266
- Marketing category
- ANDA
- Marketing start
- 2021-10-29
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213266-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | ||
| A213266-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 |
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 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213266-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213266-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2021-08-03 | bb7c543d1eb4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 | Aurohealth LLC | cbf094d4-2357-426d-8205-9b59c332854f | 2026-06-16 | Warnings | 213266 ANDA213266 |
| NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | 56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc2 | 2026-06-12 | Warnings | 213266 ANDA213266 |
| AMAZON BASIC CARE NICOTINE POLACRILEX | NICOTINE POLACRILEX | Amazon.com Services LLC | 113e0be9-7edc-4766-e063-6294a90af752 | 2025-05-02 | Warnings | 213266 ANDA213266 |
| AMAZON BASIC CARE NICOTINE POLACRILEX | NICOTINE POLACRILEX | Amazon.com Services LLC | 10ece1fa-f4c2-42ad-e063-6394a90a3a7d | 2025-05-02 | Warnings | 213266 ANDA213266 |
| NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | 810932e0-a982-400a-b43d-b847152f685b | 2022-06-24 | Warnings | 213266 ANDA213266 |
| NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | dcc0b057-3d5e-4aeb-ac31-478d7a2f47fa | 2022-06-24 | Warnings | 213266 ANDA213266 |
| NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | 1909cf25-bce8-4880-abc6-548d28a7285d | 2022-03-07 | Warnings | 213266 ANDA213266 |
| NICOTINE | NICOTINE POLACRILEX | Aurohealth LLC | fa730ae3-c2b3-4ea4-8e50-f819b205d168 | 2022-03-07 | Warnings | 213266 ANDA213266 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-0906-7 | 17856090607 | 47 POUCH in 1 BOX, UNIT-DOSE (17856-0906-7) / 1 LOZENGE in 1 POUCH | 47 pouch | 2026-10-01 | No | No | Historical |