Nicotine Polacrilex
- Product NDC
- 11822-3314
- Requested package NDC
- 11822-3314-2
- 11-digit product format
- 118223314
- Labeler code
- 11822
- Product ID
- 11822-3314_a0018572-c6b4-449d-8079-e55ac8384a46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA204833
- Marketing category
- ANDA
- Marketing start
- 2019-12-27
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 package | package | 11822-3314 | 11822-3314-2 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204833-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 |
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 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204833-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2016-02-26 | cb3db0bc1861… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-3314-8 | 2026-01-02 | C162847 | 48780-1 | 1030e365-0da8-111a-e063-dadaa90a10e2 | Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate |
| 11822-3314-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0da8-111a-e063-dadaa90a10e2 | Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-3314 | NICOTINE POLACRILEX GUM, CHEWING [RITE AID CORPORATION] | 5 | Legacy NDC | 20231102_cf0ca52f-2de7-4377-a164-1d86d462819a.zip |
| 11822-3314 | NICOTINE POLACRILEX GUM, CHEWING [RITE AID CORPORATION] | 2 | Legacy NDC | 20220114_d970580a-e36b-4bde-ac17-081611f606b3.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 | 204833 ANDA204833 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Chain Drug Consortium, LLC | 9c115cd5-1952-4f1e-8e88-27f2c528e91f | 2026-03-26 | Warnings | 204833 ANDA204833 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Family Dollar (FAMILY WELLNESS) | d353b75f-3fc3-4958-92c6-08df6bdf283c | 2026-03-18 | Warnings | 204833 ANDA204833 |
| Nicotine Polacrilex coated ice mint | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | c21147f5-da96-424c-9058-24eb751b64ea | 2026-03-17 | Warnings | 204833 ANDA204833 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ee883114-35ac-4b81-b8f1-4903d646dd84 | 2026-02-11 | Warnings | 204833 ANDA204833 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Walgreens | 5741531a-3886-4b0a-ae92-d7c238488fdf | 2026-02-04 | Warnings | 204833 ANDA204833 |
| Nicotine Polacrilex coated ice mint | NICOTINE POLACRILEX | CVS Pharmacy | e4e3fd5f-1ed1-4a18-9c31-7224cae77ded | 2024-10-03 | Warnings | 204833 ANDA204833 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-3314-2 | 11822331402 | 160 BLISTER PACK in 1 CARTON (11822-3314-2) > 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2020-01-31 | 0000-00-00 | No | No | Current |