Nicotine

Product NDC
30142-671
11-digit product format
301420671
Labeler code
30142
Product ID
30142-671_09c0b1fa-35a6-4ce6-b3e5-216c46d6f635
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
The Kroger Co.
Application
ANDA074707
Marketing category
ANDA
Marketing start
2022-06-03
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074707-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311975Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f801e8b2-b789-41f4-b35e-ea3a82d2bb9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-671-11Nicotine110 in 1 CARTONGUM, CHEWING1104
30142-671-11Nicotine1 in 1 BLISTER PACKGUM, CHEWING14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-671NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [THE KROGER CO.]3Current NDC, Legacy NDC, 2 package rows20250227_f801e8b2-b789-41f4-b35e-ea3a82d2bb9c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXP & L Development, LLC4d669f54-5031-4b89-a546-6cdefc648fc32026-06-16WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Nicotine Polacrilex originalNICOTINE POLACRILEXWalgreensf759d9b2-35e0-4b88-9219-4c0e483af5c42026-05-19WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Nicotine Polacrilex originalNICOTINE POLACRILEXCVS Pharmacy62231539-ae9f-4665-ba59-bef047e93d8a2026-05-08WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Nicotine Polacrilex OriginalNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700004acbda22-9c87-49f2-ad5f-55b1e54bdf2e2026-04-10WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
NicotineNICOTINE POLACRILEXWalgreensd6c6c753-f604-473c-88b4-b5f83f1dd2932026-03-23WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461226432c7fc-02d3-42a4-bd46-d48250a1d4d22026-03-16WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Rugby Nicotine Polacrilex Gum, Original FlavorNICOTINE POLACRILEXRugby Laboratories1fc88637-4329-486e-82ab-19eeb06080a62026-02-24WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
NicotineNICOTINE POLACRILEXThe Kroger Co.f801e8b2-b789-41f4-b35e-ea3a82d2bb9c2026-02-13WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
ndc (product): 30142-671
Nicotine Polacrilex, OriginalNICOTINE POLACRILEXChain Drug Consortium, LLCcb67cd5e-9264-4530-a678-da299476f3562025-06-30WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Rugby Nicotine Polacrilex Gum, Original FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.57e08517-4c8a-487a-bfbe-2a43f105f4b92025-06-27WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707
Nicotine Polacrilex Original FlavorNICOTINE POLACRILEXPublix Supermarkets, Inc.540c88bd-70dc-416a-8d8e-0a33b2b295632024-07-30WarningsExact identifier
application applno (ANDA): 074707
application number: ANDA074707

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNf801e8b2-b789-41f4-b35e-ea3a82d2bb9c4
311975nicotine 4 MG Chewing GumSCDf801e8b2-b789-41f4-b35e-ea3a82d2bb9c4
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYf801e8b2-b789-41f4-b35e-ea3a82d2bb9c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-671-1130142067111110 BLISTER PACK in 1 CARTON (30142-671-11) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2022-06-030000-00-00NoNoCurrent