Home NDC 56062-503 Nicotine Polacrilex
Product NDC 56062-503
11-digit product format 560620503
Labeler code 56062
Product ID 56062-503_7dd7b2b6-13c8-401b-8013-a4f86d1a3fbd
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler Publix Supermarkets, Inc.
Application ANDA079044
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 2027-01-01
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Current FDA listing Yes 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 A079044-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG 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 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A079044-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2009-07-08 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Polacrilex
Brand name suffix Coated Fruit Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 2 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 56062-503-44 Nicotine PolacrilexCoated Fruit 10 in 1 BLISTER PACK GUM, CHEWING 10 14 56062-503-44 Nicotine PolacrilexCoated Fruit 10 in 1 CARTON GUM, CHEWING 10 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56062-503 NICOTINE POLACRILEX COATED FRUIT (NICOTINE POLACRILEX) GUM, CHEWING [PUBLIX SUPERMARKETS, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240731_c161e2d6-7691-4fd0-9f91-acfc33685420.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 · 9 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 56062-503-44 56062050344 10 BLISTER PACK in 1 CARTON (56062-503-44) / 10 GUM, CHEWING in 1 BLISTER PACK 10 blister pack 2014-01-01 2027-01-01 No No Current