FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0854
11-digit product format
001130854
Labeler code
0113
Product ID
0113-0854_8208911c-77ef-4fe5-a0e9-d806046a9302
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078546
Marketing category
ANDA
Marketing start
2013-05-14
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
0113-0854-60Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0113-0854-60Good Sense Nicotine20 in 1 CARTONGUM, CHEWING208
0113-0854-78Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
0113-0854-78Good Sense Nicotine100 in 1 CARTONGUM, CHEWING1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0854-78EA - Each0113-085448587e8f-7b66-4dee-8eac-173a705eb4c212024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
SORBITOLINACTIVE INGREDIENT506T60A25RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EGOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0854GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 4 package rows20250402_b8cbb6a7-aeb4-48f3-a0ed-7ad803021752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNb8cbb6a7-aeb4-48f3-a0ed-7ad8030217528
311975nicotine 4 MG Chewing GumSCDb8cbb6a7-aeb4-48f3-a0ed-7ad8030217528
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYb8cbb6a7-aeb4-48f3-a0ed-7ad8030217528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0854-600011308546020 BLISTER PACK in 1 CARTON (0113-0854-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-05-140000-00-00NoNoCurrent
0113-0854-7800113085478100 BLISTER PACK in 1 CARTON (0113-0854-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2020-04-160000-00-00NoNoCurrent