FDA.reportPublic FDA data

Nicotine Polacrilex

Product NDC
69842-217
11-digit product format
698420217
Labeler code
69842
Product ID
69842-217_5f0324e3-b546-4cdc-af4d-e45e2052a179
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex Gum
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
CVS Pharmacy
Application
ANDA204833
Marketing category
ANDA
Marketing start
2016-05-01
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
Nicotine Polacrilex
Brand name suffix
coated ice mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

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
69842-217-15Nicotine Polacrilexcoated ice mint1 in 1 BLISTER PACKGUM, CHEWING112
69842-217-15Nicotine Polacrilexcoated ice mint20 in 1 CARTONGUM, CHEWING2012
69842-217-16Nicotine Polacrilexcoated ice mint160 in 1 CARTONGUM, CHEWING16012
69842-217-16Nicotine Polacrilexcoated ice mint1 in 1 BLISTER PACKGUM, CHEWING112
69842-217-44Nicotine Polacrilexcoated ice mint1 in 1 BLISTER PACKGUM, CHEWING112
69842-217-44Nicotine Polacrilexcoated ice mint100 in 1 CARTONGUM, CHEWING10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-217-15EA - Each69842-21721b5dd36-2224-468c-affc-5336ea72bed712023-01-09
69842-217-16EA - Each69842-217320ef691-bd0e-4893-9f15-0ce991cb480012023-01-09
69842-217-44EA - Each69842-2173af1fa6e-7c5d-4755-8a11-3616f7cc5ccd12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-217NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX GUM) GUM, CHEWING [CVS PHARMACY]12Current NDC, Legacy NDC, 6 package rows20241004_e4e3fd5f-1ed1-4a18-9c31-7224cae77ded.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12
311975nicotine polacrilex 4 MG Chewing GumPSNe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12
314119nicotine 2 MG Chewing GumSCDe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12
311975nicotine 4 MG Chewing GumSCDe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYe4e3fd5f-1ed1-4a18-9c31-7224cae77ded12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-217-156984202171520 BLISTER PACK in 1 CARTON (69842-217-15) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2016-05-010000-00-00NoNoCurrent
69842-217-1669842021716160 BLISTER PACK in 1 CARTON (69842-217-16) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2016-05-010000-00-00NoNoCurrent
69842-217-4469842021744100 BLISTER PACK in 1 CARTON (69842-217-44) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2016-05-010000-00-00NoNoCurrent