Home NDC 0536-3387-01 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor
Product NDC 0536-3387
Requested package NDC 0536-3387-01
11-digit product format 005363387
Labeler code 0536
Product ID 0536-3387_c3233d63-7235-4d38-bea1-e0f2d0fe9cd1
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler Rugby Laboratories
Application ANDA079038
Marketing category ANDA
Marketing start 2009-07-08
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079038-001 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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table 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 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079038-001 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 A079038-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2009-07-08 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311975 Internal RxNorm lookup 314119 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-3387-01 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 18 0536-3387-01 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 10 in 1 CARTON GUM, CHEWING 10 18 0536-3387-37 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 18 0536-3387-37 Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 4 in 1 CARTON GUM, CHEWING 4 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 NICOTINE ACTIVE MOIETY 6M3C89ZY6R RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 ACACIA INACTIVE INGREDIENT 5C5403N26O RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 MAGNESIUM OXIDE INACTIVE INGREDIENT 3A3U0GI71G RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-3387 RUGBY NICOTINE POLACRILEX GUM, COATED FRUIT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.] 14 Current NDC, Legacy NDC, 4 package rows 20250104_b973d045-7791-49c1-9216-4e0d51173735.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.
Matched openFDA labels page 1 of 1 · 10 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0536-3387-01 00536338701 10 BLISTER PACK in 1 CARTON (0536-3387-01) / 10 GUM, CHEWING in 1 BLISTER PACK 10 blister pack 2009-07-08 0000-00-00 No No Current