Nicotine
- Product NDC
- 49035-391
- Requested package NDC
- 49035-391-16
- 11-digit product format
- 490350391
- Labeler code
- 49035
- Product ID
- 49035-391_01f9350f-6150-47aa-ae7e-d74060625e5a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.)
- Application
- ANDA079219
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 49035-391 | 49035-391-16 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-391-10 | EA - Each | 49035-391 | be08c242-9cb3-4f43-819b-e2f4a2a7f55e | 1 | 2023-04-07 |
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 |
|---|---|---|---|---|---|---|---|---|
| 49035-391-16 | 49035039116 | 160 BLISTER PACK in 1 CARTON (49035-391-16) > 1 GUM, CHEWING in 1 BLISTER PACK | 160 blister pack | 2020-10-01 | 0000-00-00 | No | No | Current |