GOOD SENSE

Product NDC
50090-6240
11-digit product format
500906240
Labeler code
50090
Product ID
50090-6240_2f53c228-6ead-4535-9deb-ca70caa2d347
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078326
Marketing category
ANDA
Marketing start
2005-04-22
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
A078326-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30

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 UTC2026-02A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078326-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL2006-10-30cb3db0bc1861…

Additional Listing Data#

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

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
dece0a8d-a7df-446f-bfcf-9f96e8bfc4aeAvailable 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
50090-6240-0GOOD SENSE110 in 1 CARTONGUM, CHEWING1103
50090-6240-0GOOD SENSE1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6240-0EA - Each50090-62406b3f3815-9f85-43e9-9ded-f32f5434f96e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6240GOOD SENSE (NICOTINE POLACRILEX) GUM, CHEWING [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231101_dece0a8d-a7df-446f-bfcf-9f96e8bfc4ae.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc768e3f3d-d867-4574-8a5d-07572e2e4a042026-06-29WarningsExact identifier
application applno (ANDA): 078326
application number: ANDA078326
GOOD SENSENICOTINE POLACRILEXA-S Medication Solutionsdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae2023-10-31WarningsExact identifier
application applno (ANDA): 078326
application number: ANDA078326
ndc (product): 50090-6240

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae3
311975nicotine 4 MG Chewing GumSCDdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae3
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6240-050090624000110 BLISTER PACK in 1 CARTON (50090-6240-0) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2022-11-230000-00-00NoNoCurrent