Nicotine

Product NDC
37808-658
11-digit product format
378080658
Labeler code
37808
Product ID
37808-658_71077dd2-ec82-4e1a-b8fd-7a6c65628814
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
H E B
Application
ANDA076779
Marketing category
ANDA
Marketing start
2019-05-03
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
Listing expiration
2026-12-31

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-658-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
37808-658-06Nicotine160 in 1 CARTONGUM, CHEWING1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-658NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [H E B]5Current NDC, Legacy NDC, 2 package rows20250523_c690001d-12c4-4a0f-b9b0-2d2b73dcd93a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNc690001d-12c4-4a0f-b9b0-2d2b73dcd93a5
311975nicotine 4 MG Chewing GumSCDc690001d-12c4-4a0f-b9b0-2d2b73dcd93a5
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYc690001d-12c4-4a0f-b9b0-2d2b73dcd93a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-658-0637808065806160 BLISTER PACK in 1 CARTON (37808-658-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2019-05-030000-00-00NoNoCurrent