Nicorette 4mg White Ice Mint Gum, Lil Drug Store

Product NDC
66715-8125
11-digit product format
667158125
Labeler code
66715
Product ID
66715-8125_0e894f4f-2d42-24c2-e063-6294a90ae26c
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020066-002NICORETTENICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD, RS1996-02-09
N020066-003NICORETTE (MINT)NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD1998-12-23
N020066-004NICORETTENICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCALRLD2000-09-25

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N020066-00283236832028-04-30Drug product2013-01-03

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette 4mg White Ice Mint Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e894f4f-2d41-24c2-e063-6294a90ae26c2024-01-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase blood pressure. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask a doctor Stop use and ask a doctor if mouth, teeth or jaw problems occur irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Nicorette 4mg White Ice Mint Gum, Lil Drug Store
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
66715-8125-0Nicorette 4mg White Ice Mint Gum, Lil Drug Store1 in 1 CARTONGUM, CHEWING11
66715-8125-0Nicorette 4mg White Ice Mint Gum, Lil Drug Store10 in 1 BLISTER PACKGUM, CHEWING101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-8125NICORETTE 4MG WHITE ICE MINT GUM, LIL DRUG STORE (NICOTINE POLACRILEX) GUM, CHEWING [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 2 package rows20240111_0e894f4f-2d41-24c2-e063-6294a90ae26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105071Nicorette 4 MG Chewing GumPSN0e894f4f-2d41-24c2-e063-6294a90ae26c1
311975nicotine polacrilex 4 MG Chewing GumPSN0e894f4f-2d41-24c2-e063-6294a90ae26c1
105071nicotine 4 MG Chewing Gum [Nicorette]SBD0e894f4f-2d41-24c2-e063-6294a90ae26c1
311975nicotine 4 MG Chewing GumSCD0e894f4f-2d41-24c2-e063-6294a90ae26c1
105071Nicorette 4 MG Chewing GumSY0e894f4f-2d41-24c2-e063-6294a90ae26c1
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY0e894f4f-2d41-24c2-e063-6294a90ae26c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-8125-0667158125001 BLISTER PACK in 1 CARTON (66715-8125-0) / 10 GUM, CHEWING in 1 BLISTER PACK1 blister pack2022-05-06NoNoCurrent