Basic Care Nicotine

Product NDC
72288-456
11-digit product format
722880456
Labeler code
72288
Product ID
72288-456_9327c99c-b0fb-40c0-86b1-f334e26d81a1
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA076777
Marketing category
ANDA
Marketing start
2020-06-11
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72288-45672288-456-60DDiscontinued by firm2026-08-03

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72288-45672288-456-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72288-45672288-456-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076777-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG 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 UTC2026-02A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076777-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-09-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076777-001NICOTINE POLACRILEXEQ 2MG 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
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
5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e1Available 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
72288-456-06Basic Care Nicotine1 in 1 BLISTER PACKGUM, CHEWING14
72288-456-06Basic Care Nicotine160 in 1 CARTONGUM, CHEWING1604
72288-456-60Basic Care Nicotine20 in 1 CARTONGUM, CHEWING204
72288-456-60Basic Care Nicotine1 in 1 BLISTER PACKGUM, CHEWING14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-456BASIC CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 4 package rows20250303_5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e1.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
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e12026-06-24WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
ndc (product): 72288-456
NicotineNICOTINEH E B08d448f6-7cf1-4725-978a-01dfe7dc07c82026-06-18WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
quitine nicotineNICOTINE POLACRILEXQUITINE LLC88e49664-1f09-431c-a96a-92605b79c8122026-05-20WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
NicotineNICOTINE POLACRILEXRite Aid Corporationb5d5bdb5-8961-4c8a-9f58-4f23044264a62026-04-28WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
up and up coated cool mint nicotineNICOTINE POLACRILEXTarget Corporation7b5e2b0d-0c29-4cdf-acb0-a202bdb7463c2026-04-27WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company74ce5bd9-98ad-4e41-80b0-5d7aaa122ac82026-04-08WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc519788c4-10fc-4395-9114-74e996e103fa2026-04-07WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
NicotineNICOTINE POLACRILEXWalgreen Companydc1ffb6b-0865-4854-bbbd-97606995e3f42026-03-02WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC440178c0-e9e4-4729-bcd9-f640742c40802026-02-12WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
NicotineNICOTINE POLACRILEXMeijer Distribution Inc6d86cb8f-018e-41be-a6d0-9ca30e7318552026-01-29WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC48230756-9448-4957-82a6-5e7e3c2c0b572023-09-14WarningsExact identifier
application applno (ANDA): 076777
application number: ANDA076777

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e14
314119nicotine 2 MG Chewing GumSCD5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e14
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY5dedf4f4-5a1d-405c-9ac6-ff48b2c6d8e14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-456-0672288045606160 BLISTER PACK in 1 CARTON (72288-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-06-110000-00-00NoNoCurrent
72288-456-607228804566020 BLISTER PACK in 1 CARTON (72288-456-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-06-110000-00-00NoNoCurrent