Nicotine
- Product NDC
- 0363-0411
- 11-digit product format
- 003630411
- Labeler code
- 0363
- Product ID
- 0363-0411_4aba8ee5-d2b0-4f6d-ba98-03fb96877c50
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- ANDA077007
- Marketing category
- ANDA
- Marketing start
- 2006-02-23
- 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
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 | 0363-0411 | 0363-0411-06 | D | Discontinued by firm | 2026-09-14 |
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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077007-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | ||
| A077007-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 |
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 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 74a2ff9319b5… |
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
- 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#
| Identifier | FDA.report destination |
|---|---|
| 359817 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1123afbb-1785-43f0-aca4-dd5a9565d774 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0411-05 | Nicotine | 3 in 1 CARTON | LOZENGE | 3 | 8 | |
| 0363-0411-05 | Nicotine | 24 in 1 CONTAINER | LOZENGE | 24 | 8 | |
| 0363-0411-06 | Nicotine | 24 in 1 CONTAINER | LOZENGE | 24 | 8 | |
| 0363-0411-06 | Nicotine | 4 in 1 CARTON | LOZENGE | 4 | 8 | |
| 0363-0411-10 | Nicotine | 4 in 1 CARTON | LOZENGE | 4 | 8 | |
| 0363-0411-10 | Nicotine | 27 in 1 CONTAINER | LOZENGE | 27 | 8 | |
| 0363-0411-16 | Nicotine | 6 in 1 CARTON | LOZENGE | 6 | 8 | |
| 0363-0411-16 | Nicotine | 24 in 1 CONTAINER | LOZENGE | 24 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0411-05 | EA - Each | 0363-0411 | 3706e424-d873-469d-a988-d09350f732be | 1 | 2020-04-20 |
| 0363-0411-10 | EA - Each | 0363-0411 | 74db17d4-f36f-4237-860e-a7ecbabd3f95 | 1 | 2023-06-06 |
| 0363-0411-16 | EA - Each | 0363-0411 | 21cdc1a9-8d82-4e79-bffa-ad13de3ae2cb | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Rite Aid Corporation | 09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9 | 2026-09-09 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Rite Aid Corporation | c94d46b1-f526-4af0-8f7c-8261b9ed6841 | 2026-09-09 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Sixarp, LLC | 5a94092b-f80e-c656-e063-6294a90ab15a | 2026-09-03 | Warnings | 077007 ANDA077007 |
| QUITINE NICOTINE | NICOTINE POLACRILEX | QUITINE LLC | 2e24f6d7-957e-4c7c-a486-8a1c1b47d53f | 2026-08-31 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | 8430a12b-4a7b-48a1-aa8f-7e55c5fde3c0 | 2026-08-28 | Warnings | 077007 ANDA077007 |
| NICOTINE | NICOTINE POLACRILEX | Walgreen Company | 5dd116ea-d031-439c-b06c-2f77230bc446 | 2026-08-20 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | e40a534e-8083-454d-9667-826bfbac397c | 2026-08-19 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Amazon.com Services LLC | bc1b6b41-d069-470e-90ca-a441ab97f96a | 2026-08-18 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 9ba85e0a-bcb7-4803-8d21-0eb93768cb3a | 2026-08-07 | Warnings | 077007 ANDA077007 |
| Quitine Nicotine | NICOTINE POLACRILEX | QUITINE LLC | 4cc32b8c-6316-4d4b-8fa9-ef640464ca69 | 2026-08-06 | Warnings | 077007 ANDA077007 |
| nicotine | NICOTINE POLACRILEX | Publix Super Markets Inc | 00b40bb3-3785-4a53-804e-633795e87f71 | 2026-07-20 | Warnings | 077007 ANDA077007 |
| EQUATE NICOTINE | NICOTINE POLACRILEX | WALMART INC. | b6379f86-1528-465d-9527-bd2fead0068f | 2026-07-15 | Warnings | 077007 ANDA077007 |
| Good Sense Nicotine | NICOTINE POLACRILEX | L. Perrigo Company | 5c89061b-1452-4962-9f25-212f2ae8e41e | 2026-07-13 | Warnings | 077007 ANDA077007 |
| nicotine coated | NICOTINE POLACRILEX | Publix Super Markets Inc | a0113a1d-3691-4f18-9950-ae6d8d7d19ea | 2026-07-10 | Warnings | 077007 ANDA077007 |
| NICOTINE | NICOTINE POLACRILEX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0ef9e55d-83e0-4ba5-a905-8cddb0db0019 | 2026-07-09 | Warnings | 077007 ANDA077007 |
| nicotine coated | NICOTINE POLACRILEX | Publix Super Markets Inc | 8cb5577b-48c0-47f8-8979-0ab54d713045 | 2026-07-09 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Kroger Company | 35f45900-af2e-4b74-9772-8beb55236457 | 2026-06-26 | Warnings | 077007 ANDA077007 |
| quitine nicotine | NICOTINE POLACRILEX | QUITINE LLC | 21014e98-2c7c-4cc6-8595-a717910710a4 | 2026-06-26 | Warnings | 077007 ANDA077007 |
| quitine nicotine | NICOTINE POLACRILEX | QUITINE LLC | fd9ce0e2-b159-4e0d-a76e-7223d36810fb | 2026-06-26 | Warnings | 077007 ANDA077007 |
| Nicotine | NICOTINE POLACRILEX | Kroger Company | 0ef57432-471d-4c7a-b8be-0f898f01d197 | 2026-06-26 | Warnings | 077007 ANDA077007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 359817 | nicotine 2 MG Oral Lozenge | PSN | 1123afbb-1785-43f0-aca4-dd5a9565d774 | 8 |
| 359817 | nicotine 2 MG Oral Lozenge | SCD | 1123afbb-1785-43f0-aca4-dd5a9565d774 | 8 |
| 359817 | nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge | SY | 1123afbb-1785-43f0-aca4-dd5a9565d774 | 8 |
| 359817 | nicotine 2 MG Troche | SY | 1123afbb-1785-43f0-aca4-dd5a9565d774 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0411-05 | 00363041105 | 3 CONTAINER in 1 CARTON (0363-0411-05) / 24 LOZENGE in 1 CONTAINER | 3 container | 2010-06-23 | 0000-00-00 | No | No | Current |
| 0363-0411-06 | 00363041106 | 4 CONTAINER in 1 CARTON (0363-0411-06) > 24 LOZENGE in 1 CONTAINER | 4 container | 2015-08-16 | 0000-00-00 | No | No | Current |
| 0363-0411-10 | 00363041110 | 4 CONTAINER in 1 CARTON (0363-0411-10) / 27 LOZENGE in 1 CONTAINER | 4 container | 2013-02-22 | 0000-00-00 | No | No | Current |
| 0363-0411-16 | 00363041116 | 6 CONTAINER in 1 CARTON (0363-0411-16) / 24 LOZENGE in 1 CONTAINER | 6 container | 2015-10-08 | 0000-00-00 | No | No | Current |