Mini Nicotine
- Product NDC
- 11822-3622
- 11-digit product format
- 118223622
- Labeler code
- 11822
- Product ID
- 11822-3622_8b2abd2a-247b-4fc6-9087-3cc9afc32616
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA207868
- Marketing category
- ANDA
- Marketing start
- 2019-12-27
- 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 | 11822-3622 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 11822-3622 | 11822-3622-5 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207868-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | ||
| A207868-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 |
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 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207868-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207868-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2019-02-07 | 782e0a99824c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A207868-001 | PC | 2019-10-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207868-002 | PC | 2019-10-01 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A207868-001 | PC | 2019-10-01 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207868-002 | PC | 2019-10-01 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207868-001 | PC | 2019-10-01 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207868-002 | PC | 2019-10-01 | b00525d2431f… |
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 |
|---|---|---|---|---|
| 11822-3622 | MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [RITE AID CORPORATION] | 4 | Legacy NDC | 20220125_8bafad28-d671-4ff3-8288-6fd19ae43293.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 |
|---|---|---|---|---|---|---|
| Mini Nicotine | NICOTINE POLACRILEX | WALMART INC. (see also Equate) | 286e2768-ad98-43be-a3be-a2db0370f50f | 2026-07-09 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | WALMART INC. (see also Equate) | b49546cd-6cc4-422c-9a72-3a1faf2abcd3 | 2026-07-09 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | P & L Development, LLC | b105adbd-b306-4944-a1d8-f209b74606c9 | 2026-06-24 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | P & L Development, LLC | 9ddc3fde-f384-41d2-93d5-077b6e419029 | 2026-06-24 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | Walgreens | dfdd100d-8808-40f4-a68e-1e0388be424d | 2026-05-08 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | Walgreens | 60551e9a-c82f-45ce-8ef4-03c00c6c870a | 2026-05-06 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | HC Jones, Inc. | d0d1a5ef-fd4c-4854-9453-68808cc0fab0 | 2026-04-07 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | HC Jones, Inc. | ff9e34ff-5086-4e1b-9220-27ac2ac1069c | 2026-04-07 | Warnings | 207868 ANDA207868 |
| Nicotine Sugar Free | NICOTINE POLACRILEX | CVS Pharmacy | 9a96ba38-e696-4465-9869-9b269dc18f8d | 2026-01-27 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | Rising Pharma Holdings, Inc. | 05990040-5bd7-4622-8fe3-2d7573904dfa | 2025-12-06 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | Rugby Laboratories, Inc. | 237471f8-ce0f-423b-993f-b4380fd890ff | 2025-09-02 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | Rite Aid Corporation | 876b80a3-3ea8-4821-9716-c18e24502822 | 2025-08-20 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | Rugby Laboratories, Inc. | be17cbe9-43bb-424e-9d91-fba4f02691bb | 2025-07-18 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | Chain Drug Consortium, LLC | 380ce6c2-3e29-4bdf-a600-f6990925a307 | 2025-06-30 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | ATLANTIC BIOLOGICALS CORP. | 31e0dadd-2678-4e3c-9e62-e3766c21ce5f | 2025-06-27 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | ATLANTIC BIOLOGICALS CORP. | a0fc3eae-9c34-48af-bdd2-d95e91b68a9c | 2025-06-27 | Warnings | 207868 ANDA207868 |
| Nicotine Mini | NICOTINE POLACRILEX | PLD Acquisitions LLC DBA Avma Pharma Solutions | 71db232e-b169-47d0-b269-5e14fa75f3a2 | 2025-03-27 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 9b1d9efc-f74b-42f5-be84-5142ee168767 | 2025-01-30 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 7f1cdc21-d213-4ede-86fd-e11b31dfab58 | 2025-01-30 | Warnings | 207868 ANDA207868 |
| Mini Nicotine | NICOTINE POLACRILEX | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4856d5df-3b77-465e-b6a9-38d00854f967 | 2023-10-23 | Warnings | 207868 ANDA207868 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11822-3622-5 | 11822362205 | 3 BOTTLE, PLASTIC in 1 BOX (11822-3622-5) > 27 LOZENGE in 1 BOTTLE, PLASTIC | 2019-12-27 | 0000-00-00 | No | No | Current |