FDA.reportPublic FDA data

good sense nicotine

Product NDC
0113-8100
11-digit product format
001138100
Labeler code
0113
Product ID
0113-8100_f02262f9-5474-440b-b1fe-ddee10e45be5
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA206394
Marketing category
ANDA
Marketing start
2023-06-21
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
0113-8100-00good sense nicotine310 in 1 CARTONGUM, CHEWING3103
0113-8100-00good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING13
0113-8100-25good sense nicotine110 in 1 CARTONGUM, CHEWING1103
0113-8100-25good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING13
0113-8100-29good sense nicotine220 in 1 CARTONGUM, CHEWING2203
0113-8100-29good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-8100-25EA - Each0113-8100e823769c-e0fc-4840-87ee-855e82873d2012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-8100GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2Current NDC, 6 package rows20250130_ba373c62-65eb-43ad-88e3-bb2c13df588c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNaf4323b6-5240-4697-992a-512c4d0983403
314119nicotine polacrilex 2 MG Chewing GumPSNba373c62-65eb-43ad-88e3-bb2c13df588c3
314119nicotine 2 MG Chewing GumSCDaf4323b6-5240-4697-992a-512c4d0983403
314119nicotine 2 MG Chewing GumSCDba373c62-65eb-43ad-88e3-bb2c13df588c3
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYaf4323b6-5240-4697-992a-512c4d0983403
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYba373c62-65eb-43ad-88e3-bb2c13df588c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-8100-0000113810000310 BLISTER PACK in 1 CARTON (0113-8100-00) / 1 GUM, CHEWING in 1 BLISTER PACK310 blister pack2026-02-26NoNoHistorical
0113-8100-2500113810025110 BLISTER PACK in 1 CARTON (0113-8100-25) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2023-06-21NoNoHistorical
0113-8100-2900113810029220 BLISTER PACK in 1 CARTON (0113-8100-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2026-01-02NoNoHistorical