FDA.reportPublic FDA data

Nicorette 4mg Cinnamon Surge

Product NDC
66715-8123
11-digit product format
667158123
Labeler code
66715
Product ID
66715-8123_0e74e9fd-f79b-ffea-e063-6394a90a721e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Lil' Drug Store products, Inc.
Application
NDA020066
Marketing category
NDA
Marketing start
2022-05-06
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
Nicorette 4mg Cinnamon Surge
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui105071, 311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-8123-0Nicorette 4mg Cinnamon Surge1 in 1 CARTONGUM, CHEWING11
66715-8123-0Nicorette 4mg Cinnamon Surge10 in 1 BLISTER PACKGUM, CHEWING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-8123NICORETTE 4MG CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 2 package rows20240110_0e74e9fd-f79a-ffea-e063-6394a90a721e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105071Nicorette 4 MG Chewing GumPSN0e74e9fd-f79a-ffea-e063-6394a90a721e1
311975nicotine polacrilex 4 MG Chewing GumPSN0e74e9fd-f79a-ffea-e063-6394a90a721e1
105071nicotine 4 MG Chewing Gum [Nicorette]SBD0e74e9fd-f79a-ffea-e063-6394a90a721e1
311975nicotine 4 MG Chewing GumSCD0e74e9fd-f79a-ffea-e063-6394a90a721e1
105071Nicorette 4 MG Chewing GumSY0e74e9fd-f79a-ffea-e063-6394a90a721e1
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY0e74e9fd-f79a-ffea-e063-6394a90a721e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-8123-0667158123001 BLISTER PACK in 1 CARTON (66715-8123-0) / 10 GUM, CHEWING in 1 BLISTER PACK1 blister pack2022-05-06NoNoHistorical