Nicotine

Product NDC
30142-859
11-digit product format
301420859
Labeler code
30142
Product ID
30142-859_7b37f038-65cd-4c84-ae4f-6bee26aab6d1
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
The Kroger Co.
Application
ANDA074507
Marketing category
ANDA
Marketing start
2022-06-03
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A074507-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15

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.

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 UTC2026-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 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
314119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c81c885-1d56-4dca-b9bc-adfc9bf58051Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-859-11Nicotine110 in 1 CARTONGUM, CHEWING1103
30142-859-11Nicotine1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-859NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [THE KROGER CO.]3Current NDC, Legacy NDC, 2 package rows20250227_8c81c885-1d56-4dca-b9bc-adfc9bf58051.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, LLCc65c1c40-4c8f-40bb-ace4-8bbc9ecf630e2026-06-16WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
Nicotine Polacrilex originalNICOTINE POLACRILEXWalgreensf759d9b2-35e0-4b88-9219-4c0e483af5c42026-05-19WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
Nicotine Polacrilex originalNICOTINE POLACRILEXCVS Pharmacy62231539-ae9f-4665-ba59-bef047e93d8a2026-05-08WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
Nicotine Polacrilex OriginalNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700004acbda22-9c87-49f2-ad5f-55b1e54bdf2e2026-04-10WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
NicotineNICOTINE POLACRILEXWalgreens69ffbb37-e26c-4214-8d09-0bbabed253102026-03-20WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122be693c28-58d5-42ed-ab86-2a28af9310512026-03-17WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
Rugby Nicotine Polacrilex Gum, Original FlavorNICOTINE POLACRILEXRugby Laboratories1fc88637-4329-486e-82ab-19eeb06080a62026-02-24WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
NicotineNICOTINE POLACRILEXMcKesson Corporation dba SKY Packaging9ac37719-24c2-4ec7-9fb3-6408d8a5fc7a2026-01-09WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
Nicotine Polacrilex, OriginalNICOTINE POLACRILEXChain Drug Consortium, LLCcb67cd5e-9264-4530-a678-da299476f3562025-06-30WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
NicotineNICOTINE POLACRILEXThe Kroger Co.8c81c885-1d56-4dca-b9bc-adfc9bf580512025-02-25WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507
ndc (product): 30142-859
Nicotine Polacrilex Original FlavorNICOTINE POLACRILEXPublix Supermarkets, Inc.540c88bd-70dc-416a-8d8e-0a33b2b295632024-07-30WarningsExact identifier
application applno (ANDA): 074507
application number: ANDA074507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN8c81c885-1d56-4dca-b9bc-adfc9bf580513
314119nicotine 2 MG Chewing GumSCD8c81c885-1d56-4dca-b9bc-adfc9bf580513
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY8c81c885-1d56-4dca-b9bc-adfc9bf580513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-859-1130142085911110 BLISTER PACK in 1 CARTON (30142-859-11) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2022-06-030000-00-00NoNoCurrent