Rugby Nicotine Polacrilex Gum, Mint Flavor
- Product NDC
- 50090-1151
- Requested package NDC
- 50090-1151-0
- 11-digit product format
- 500901151
- Labeler code
- 50090
- Product ID
- 50090-1151_a1dc4fab-44e6-4477-8042-a16d8efa4a20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076568
- Marketing category
- ANDA
- Marketing start
- 2004-07-29
- 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 | 50090-1151 | 50090-1151-0 | I | Inactivated by FDA | 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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076568-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 |
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 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076568-002 | NICOTINE POLACRILEX | EQ 4MG BASE | GUM, CHEWING / BUCCAL | 2004-07-29 | 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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1151-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f0d6-0266-e053-dadaa90a7c1a | Nicotine Polacrilex Gum 2 mg and 4 mg MINT - Rugby |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1151-0 | Rugby Nicotine Polacrilex Gum, Mint Flavor | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | 13 | |
| 50090-1151-0 | Rugby Nicotine Polacrilex Gum, Mint Flavor | 11 in 1 CARTON | GUM, CHEWING | 11 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1151-0 | EA - Each | 50090-1151 | bf35f097-570f-4706-bb7f-599803f7a087 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1151 | RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [A-S MEDICATION SOLUTIONS] | 13 | Legacy NDC, 2 package rows | 20210416_7bc144bb-6a7a-42a8-8210-15762e35e4de.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 MINT | NICOTINE POLACRILEX | Walgreens | 53c5ae28-5638-4217-9080-2bceba9a8885 | 2026-05-19 | Warnings | 076568 ANDA076568 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 51cf7563-889d-4726-8f4c-e8efe0290432 | 2026-03-18 | Warnings | 076568 ANDA076568 |
| Nicotine Polacrilex | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 03d0bfa1-cb23-408a-8d8e-24aa0e05bf4f | 2026-03-18 | Warnings | 076568 ANDA076568 |
| Rugby Nicotine Polacrilex Gum, Mint Flavor | NICOTINE POLACRILEX | Rugby Laboratories | 0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25 | 2026-02-26 | Warnings | 076568 ANDA076568 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311975 | nicotine polacrilex 4 MG Chewing Gum | PSN | 7bc144bb-6a7a-42a8-8210-15762e35e4de | 13 |
| 311975 | nicotine 4 MG Chewing Gum | SCD | 7bc144bb-6a7a-42a8-8210-15762e35e4de | 13 |
| 311975 | nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum | SY | 7bc144bb-6a7a-42a8-8210-15762e35e4de | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-1151-0 | 50090115100 | 11 BLISTER PACK in 1 CARTON (50090-1151-0) > 10 GUM, CHEWING in 1 BLISTER PACK | 11 blister pack | 2014-11-28 | 0000-00-00 | No | No | Current |