Rugby Nicotine Polacrilex Gum, Original Flavor
- Product NDC
- 0536-3029
- 11-digit product format
- 005363029
- Labeler code
- 0536
- Product ID
- 0536-3029_a7fad73a-749d-4287-b756-2cd203b85d35
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- BUCCAL
- Labeler
- Rugby Laboratories
- Application
- ANDA074507
- Marketing category
- ANDA
- Marketing start
- 1999-03-15
- Substance
- NICOTINE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074507-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A074507-001 | NICOTINE POLACRILEX | EQ 2MG BASE | GUM, CHEWING / BUCCAL | 1999-03-15 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NICOTINE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6M3C89ZY6R | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1fc88637-4329-486e-82ab-19eeb06080a6 | Available on FDA.report |
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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | 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 |
|---|---|---|---|---|---|---|
| 0536-3029-06 | Rugby Nicotine Polacrilex Gum, Original Flavor | 5 in 1 CARTON | GUM, CHEWING | 5 | 27 | |
| 0536-3029-06 | Rugby Nicotine Polacrilex Gum, Original Flavor | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | 27 | |
| 0536-3029-23 | Rugby Nicotine Polacrilex Gum, Original Flavor | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | 27 | |
| 0536-3029-23 | Rugby Nicotine Polacrilex Gum, Original Flavor | 11 in 1 CARTON | GUM, CHEWING | 11 | 27 | |
| 0536-3029-34 | Rugby Nicotine Polacrilex Gum, Original Flavor | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | 27 | |
| 0536-3029-34 | Rugby Nicotine Polacrilex Gum, Original Flavor | 2 in 1 CARTON | GUM, CHEWING | 2 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-3029-06 | EA - Each | 0536-3029 | 79319670-6345-4500-bbe6-1a7d03fcfa9b | 1 | 2013-02-13 |
| 0536-3029-23 | EA - Each | 0536-3029 | 7bff0082-17f6-4473-81d4-a7be7cc0de71 | 1 | 2013-02-13 |
| 0536-3029-34 | EA - Each | 0536-3029 | 0fc17380-3c30-449e-ad0d-ef03c3755ea3 | 1 | 2013-02-13 |
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 | Rugby Laboratories | 1fc88637-4329-486e-82ab-19eeb06080a6 | 2026-07-15 | Warnings | 074507 ANDA074507 0536-3029 |
| Nicotine | NICOTINE POLACRILEX | P & L Development, LLC | c65c1c40-4c8f-40bb-ace4-8bbc9ecf630e | 2026-06-16 | Warnings | 074507 ANDA074507 |
| Nicotine Polacrilex original | NICOTINE POLACRILEX | Walgreens | f759d9b2-35e0-4b88-9219-4c0e483af5c4 | 2026-05-19 | Warnings | 074507 ANDA074507 |
| Nicotine Polacrilex original | NICOTINE POLACRILEX | CVS Pharmacy | 62231539-ae9f-4665-ba59-bef047e93d8a | 2026-05-08 | Warnings | 074507 ANDA074507 |
| Nicotine Polacrilex Original | NICOTINE POLACRILEX | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 4acbda22-9c87-49f2-ad5f-55b1e54bdf2e | 2026-04-10 | Warnings | 074507 ANDA074507 |
| Nicotine | NICOTINE POLACRILEX | Walgreens | 69ffbb37-e26c-4214-8d09-0bbabed25310 | 2026-03-20 | Warnings | 074507 ANDA074507 |
| Nicotine | NICOTINE POLACRILEX | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | be693c28-58d5-42ed-ab86-2a28af931051 | 2026-03-17 | Warnings | 074507 ANDA074507 |
| Nicotine | NICOTINE POLACRILEX | McKesson Corporation dba SKY Packaging | 9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a | 2026-01-09 | Warnings | 074507 ANDA074507 |
| Nicotine Polacrilex, Original | NICOTINE POLACRILEX | Chain Drug Consortium, LLC | cb67cd5e-9264-4530-a678-da299476f356 | 2025-06-30 | Warnings | 074507 ANDA074507 |
| Nicotine | NICOTINE POLACRILEX | The Kroger Co. | 8c81c885-1d56-4dca-b9bc-adfc9bf58051 | 2025-02-25 | Warnings | 074507 ANDA074507 |
| Nicotine Polacrilex Original Flavor | NICOTINE POLACRILEX | Publix Supermarkets, Inc. | 540c88bd-70dc-416a-8d8e-0a33b2b29563 | 2024-07-30 | Warnings | 074507 ANDA074507 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314119 | nicotine polacrilex 2 MG Chewing Gum | PSN | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
| 311975 | nicotine polacrilex 4 MG Chewing Gum | PSN | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
| 314119 | nicotine 2 MG Chewing Gum | SCD | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
| 311975 | nicotine 4 MG Chewing Gum | SCD | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
| 314119 | nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum | SY | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
| 311975 | nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum | SY | 1fc88637-4329-486e-82ab-19eeb06080a6 | 27 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0536-3029-06 | 00536302906 | 5 BLISTER PACK in 1 CARTON (0536-3029-06) / 10 GUM, CHEWING in 1 BLISTER PACK | 5 blister pack | 1999-03-15 | 0000-00-00 | No | No | Current |
| 0536-3029-23 | 00536302923 | 11 BLISTER PACK in 1 CARTON (0536-3029-23) / 10 GUM, CHEWING in 1 BLISTER PACK | 11 blister pack | 1999-03-15 | 0000-00-00 | No | No | Current |
| 0536-3029-34 | 00536302934 | 2 BLISTER PACK in 1 CARTON (0536-3029-34) / 10 GUM, CHEWING in 1 BLISTER PACK | 2 blister pack | 1999-03-15 | 0000-00-00 | No | No | Current |