Nicotine
- Product NDC
- 55154-6818
- Requested package NDC
- 55154-6818-0
- 11-digit product format
- 551546818
- Labeler code
- 55154
- Product ID
- 55154-6818_ebab2c3a-4fda-40d6-8f54-972e1c6ee69a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA076569
- Marketing category
- ANDA
- Marketing start
- 2026-08-24
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076569-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 |
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 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076569-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | f41ea6bd6efb… |
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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 314119 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ebab2c3a-4fda-40d6-8f54-972e1c6ee69a | Available on FDA.report |
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 | Cardinal Health 107, LLC | ebab2c3a-4fda-40d6-8f54-972e1c6ee69a | 2026-08-24 | Warnings | 076569 ANDA076569 55154-6818-0 55154-6818 55154681800 |
| Nicotine | NICOTINE POLACRILEX | Rugby Laboratories | 0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25 | 2026-07-10 | Warnings | 076569 ANDA076569 |
| Nicotine Polacrilex MINT | NICOTINE POLACRILEX | Walgreens | 53c5ae28-5638-4217-9080-2bceba9a8885 | 2026-05-19 | Warnings | 076569 ANDA076569 |
| Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 5efd7a3c-b36c-4355-a646-bfeb7ba30ce5 | 2026-03-17 | Warnings | 076569 ANDA076569 |
| Rugby Nicotine Polacrilex Gum, Mint Flavor | NICOTINE POLACRILEX | A-S Medication Solutions | 7b70162e-0087-466f-9b8b-8289b6e90e39 | 2025-09-23 | Warnings | 076569 ANDA076569 |
| Rugby Nicotine Polacrilex Gum, Mint Flavor | NICOTINE POLACRILEX | ATLANTIC BIOLOGICALS CORP. | 62609a8d-bcbe-420c-aed8-edfdf022ff26 | 2025-06-27 | Warnings | 076569 ANDA076569 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55154-6818-0 | 55154681800 | 10 BLISTER PACK in 1 BAG (55154-6818-0) / 1 GUM, CHEWING in 1 BLISTER PACK | 10 blister pack | 2026-08-24 | No | No | Current |