Nicotine

Product NDC
37808-711
11-digit product format
378080711
Labeler code
37808
Product ID
37808-711_14c5b2e9-68c6-4bb3-98ac-5be533dc125d
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
H E B
Application
ANDA206394
Marketing category
ANDA
Marketing start
2019-05-02
Substance
NICOTINE
Active strength
2 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
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
37808-711-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING15
37808-711-06Nicotine160 in 1 CARTONGUM, CHEWING1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-711NICOTINE GUM, CHEWING [H E B]5Current NDC, Legacy NDC, 2 package rows20250427_da70bf12-4454-40ac-8cfd-8b7697496d55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNda70bf12-4454-40ac-8cfd-8b7697496d555
314119nicotine 2 MG Chewing GumSCDda70bf12-4454-40ac-8cfd-8b7697496d555
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYda70bf12-4454-40ac-8cfd-8b7697496d555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-711-0637808071106160 BLISTER PACK in 1 CARTON (37808-711-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2019-05-020000-00-00NoNoCurrent