Nicotine Polacrilex
- Product NDC
- 11822-2128
- 11-digit product format
- 118222128
- Labeler code
- 11822
- Product ID
- 11822-2128_1a8844da-40e5-456b-966e-a01e8d0f9946
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA079219
- Marketing category
- ANDA
- Marketing start
- 2020-01-31
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- 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 product | product | 11822-2128 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 11822-2128 | 11822-2128-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 11822-2128 | 11822-2128-4 | 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 |
|---|---|---|---|---|---|---|---|
| A079219-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 |
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 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A079219-001 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2009-07-08 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-2128 | NICOTINE POLACRILEX GUM, CHEWING [RITE AID CORPORATION] | 5 | Legacy NDC | 20220120_a0849cb5-7fa2-4b48-bd5a-e1a32b208b91.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 cinnamon | NICOTINE POLACRILEX | CVS Pharmacy | d9da6bd9-f655-446d-98b8-5b22db80dad2 | 2026-05-12 | Warnings | 079219 ANDA079219 |
| Nicotine | NICOTINE POLACRILEX | H E B | 056ca637-d5b9-4790-a5a4-c9b58f93e88b | 2026-04-02 | Warnings | 079219 ANDA079219 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | Rugby Laboratories | d67149d5-4766-4b84-8205-f1a6b692f4c9 | 2026-02-26 | Warnings | 079219 ANDA079219 |
| Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon | NICOTINE POLACRILEX | Dr. Reddy's Laboratories Inc. | 5c394758-1179-455a-a562-c8e954fb2258 | 2025-12-23 | Warnings | 079219 ANDA079219 |
| Nicotine | NICOTINE POLACRILEX | Lucy Goods, Inc. | bca1c2ab-2263-429d-9f09-f848dd3d826e | 2025-07-21 | Warnings | 079219 ANDA079219 |
| Nicotine | NICOTINE POLACRILEX | McKesson Corporation dba SKY Packaging | 0b6880c8-04e7-418a-98d1-0c7d19e025b3 | 2025-03-06 | Warnings | 079219 ANDA079219 |
| Nicotine | NICOTINE POLACRILEX | Walgreens | d933d32c-cb4a-41b2-9563-da74cf2d77e4 | 2022-10-06 | Warnings | 079219 ANDA079219 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-2128-3 | 11822212803 | 20 BLISTER PACK in 1 CARTON (11822-2128-3) > 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2020-01-31 | 0000-00-00 | No | No | Current |
| 11822-2128-4 | 11822212804 | 100 BLISTER PACK in 1 CARTON (11822-2128-4) > 1 GUM, CHEWING in 1 BLISTER PACK | 100 blister pack | 2020-01-31 | 0000-00-00 | No | No | Current |