basic care nicotine

Product NDC
72288-532
11-digit product format
722880532
Labeler code
72288
Product ID
72288-532_874e7561-0aab-4d91-a3b6-45143010d7f2
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA076779
Marketing category
ANDA
Marketing start
2020-10-29
Substance
NICOTINE
Active strength
4 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
A076779-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16

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 UTC2026-02A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076779-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2004-09-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
basic care 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
fa4d83cd-5998-440c-9d20-1d880996994dAvailable 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
72288-532-06basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-532-06basic care nicotine160 in 1 CARTONGUM, CHEWING1603
72288-532-60basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-532-60basic care nicotine20 in 1 CARTONGUM, CHEWING203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-532BASIC CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 4 package rows20250322_fa4d83cd-5998-440c-9d20-1d880996994d.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCfa4d83cd-5998-440c-9d20-1d880996994d2026-06-25WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
ndc (product): 72288-532
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCfa916f6b-0582-4e2a-bbed-6c47778c5d032026-06-19WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
NicotineNICOTINE POLACRILEXH E Bc690001d-12c4-4a0f-b9b0-2d2b73dcd93a2026-06-18WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
dg health nicotineNICOTINE POLACRILEXDolgencorp Inc64b2982d-491e-42e7-b65e-7abf5530b9352026-06-11WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
quitine nicotineNICOTINE POLACRILEXQUITINE LLC302f4785-77e6-433f-83d9-d0d2618d5ef22026-05-20WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
NicotineNICOTINE POLACRILEXWalgreen Companyc44821ba-5c2a-4586-8210-afc02a4031d52026-05-05WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
NicotineNICOTINE POLACRILEXRite Aid Corporationdc4d4fe1-6a60-4f02-b04f-a500e22d25da2026-04-28WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
Foster and Thrive NicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC23d8c1a7-a1e4-488d-bc66-b22683abf08b2026-04-27WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company788214db-3f78-4209-b3b6-d59cc9be34212026-02-18WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
NicotineNICOTINE POLACRILEXMeijer Distribution Incb451316e-6c78-4156-ad28-c10166deec792026-01-29WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inca1c85adc-8b42-40ad-91b4-0bf92a6341a52025-09-16WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779
Up and Up NicotineNICOTINE POLACRILEXTarget Corporationa4bf013b-286b-486c-bb8f-2defb3881d4c2024-04-21WarningsExact identifier
application applno (ANDA): 076779
application number: ANDA076779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNfa4d83cd-5998-440c-9d20-1d880996994d3
311975nicotine 4 MG Chewing GumSCDfa4d83cd-5998-440c-9d20-1d880996994d3
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYfa4d83cd-5998-440c-9d20-1d880996994d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-532-0672288053206160 BLISTER PACK in 1 CARTON (72288-532-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-10-290000-00-00NoNoCurrent
72288-532-607228805326020 BLISTER PACK in 1 CARTON (72288-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-11-020000-00-00NoNoCurrent