Nicotine Polacrilex
- Product NDC
- 69842-216
- 11-digit product format
- 698420216
- Labeler code
- 69842
- Product ID
- 69842-216_5f0324e3-b546-4cdc-af4d-e45e2052a179
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- CVS Pharmacy
- Application
- ANDA204794
- Marketing category
- ANDA
- Marketing start
- 2016-05-01
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204794-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204794-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 2016-05-10 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine Polacrilex
- Brand name suffix
- coated ice mint
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69842-216-15 | Nicotine Polacrilexcoated ice mint | 20 in 1 CARTON | GUM, CHEWING | 20 | 12 | |
| 69842-216-15 | Nicotine Polacrilexcoated ice mint | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | 12 | |
| 69842-216-16 | Nicotine Polacrilexcoated ice mint | 160 in 1 CARTON | GUM, CHEWING | 160 | 12 | |
| 69842-216-16 | Nicotine Polacrilexcoated ice mint | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | 12 | |
| 69842-216-44 | Nicotine Polacrilexcoated ice mint | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | 12 | |
| 69842-216-44 | Nicotine Polacrilexcoated ice mint | 100 in 1 CARTON | GUM, CHEWING | 100 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69842-216 | NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX GUM) GUM, CHEWING [CVS PHARMACY] | 12 | Current NDC, Legacy NDC, 6 package rows | 20241004_e4e3fd5f-1ed1-4a18-9c31-7224cae77ded.zip |
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 Polacrilex Coated Ice Mint | NICOTINE POLACRILEX | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | b075c3cb-d610-4a9c-8cf0-e4b9001bc86a | 2026-04-13 | Warnings | 204794 ANDA204794 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Chain Drug Consortium, LLC | 9c115cd5-1952-4f1e-8e88-27f2c528e91f | 2026-03-26 | Warnings | 204794 ANDA204794 |
| Nicotine Polacrilex coated ice mint | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | c21147f5-da96-424c-9058-24eb751b64ea | 2026-03-17 | Warnings | 204794 ANDA204794 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Walgreens | b3e33137-bf40-4801-b01f-27a0d41edba4 | 2026-02-10 | Warnings | 204794 ANDA204794 |
| Nicotine Polacrilex coated ice mint | NICOTINE POLACRILEX | CVS Pharmacy | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 2024-10-03 | Warnings | 204794 ANDA204794 69842-216 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314119 | nicotine polacrilex 2 MG Chewing Gum | PSN | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
| 311975 | nicotine polacrilex 4 MG Chewing Gum | PSN | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
| 314119 | nicotine 2 MG Chewing Gum | SCD | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
| 311975 | nicotine 4 MG Chewing Gum | SCD | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
| 314119 | nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum | SY | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
| 311975 | nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum | SY | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69842-216-15 | 69842021615 | 20 BLISTER PACK in 1 CARTON (69842-216-15) / 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2016-05-01 | 0000-00-00 | No | No | Current |
| 69842-216-16 | 69842021616 | 160 BLISTER PACK in 1 CARTON (69842-216-16) / 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2016-05-01 | 0000-00-00 | No | No | Current |
| 69842-216-44 | 69842021644 | 100 BLISTER PACK in 1 CARTON (69842-216-44) / 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2016-05-01 | 0000-00-00 | No | No | Current |