Home NDC 63868-167 Nicotine Polacrilex
Product NDC 63868-167
11-digit product format 638680167
Labeler code 63868
Product ID 63868-167_6d10f27b-9cd5-420a-bfc7-aad952b07f58
Type HUMAN OTC DRUG
Nonproprietary name Nicoitne Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application ANDA078697
Marketing category ANDA
Marketing start 2016-07-01
Marketing end 0000-00-00
Substance NICOTINE
Active strength 4 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63868-167-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63868-167-20 f5e01cc5f278…a2eaf40c39c3…
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 A078697-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29
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.
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 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-167 NICOTINE POLACRILEX GUM, CHEWING NICOTINE POLACRILEX (NICOITNE POLACRILEX) GUM, CHEWING [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 7 Legacy NDC 20230509_ed71a525-c738-4df1-b5d7-9352e17f9166.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 · 14 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-167-20 63868016720 20 BLISTER PACK in 1 CARTON (63868-167-20) > 1 GUM, CHEWING in 1 BLISTER PACK 20 blister pack 2016-07-01 0000-00-00 No No Current