FDA.reportPublic FDA data

good sense nicotine

Product NDC
0113-8600
11-digit product format
001138600
Labeler code
0113
Product ID
0113-8600_98afd600-4543-48f7-9e34-2f83b8125eba
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-08-23
Substance
NICOTINE
Active strength
4 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
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-8600-01good sense nicotine310 in 1 CARTONGUM, CHEWING3103
0113-8600-01good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING13
0113-8600-25good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING13
0113-8600-25good sense nicotine110 in 1 CARTONGUM, CHEWING1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-8600-25EA - Each0113-8600a9b1d8ad-c357-49f0-b58d-b8eaab4cf4f512024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-8600GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2Current NDC, 4 package rows20250124_eefcb8f8-4334-4e75-8e52-ef1ffbf3f0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a93
311975nicotine 4 MG Chewing GumSCDeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a93
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a93
311975nicotine polacrilex 4 MG Chewing GumPSN24cffa97-44fb-4b29-a876-b9c040b607481
311975nicotine 4 MG Chewing GumSCD24cffa97-44fb-4b29-a876-b9c040b607481
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY24cffa97-44fb-4b29-a876-b9c040b607481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-8600-0100113860001310 BLISTER PACK in 1 CARTON (0113-8600-01) / 1 GUM, CHEWING in 1 BLISTER PACK310 blister pack2026-01-02NoNoHistorical
0113-8600-2500113860025110 BLISTER PACK in 1 CARTON (0113-8600-25) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2023-08-23NoNoHistorical