signature care nicotine

Product NDC
21130-186
11-digit product format
211300186
Labeler code
21130
Product ID
21130-186_409701f5-566e-41c9-8c83-0c7203b7c59e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Safeway
Application
ANDA206394
Marketing category
ANDA
Marketing start
2018-08-27
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
signature care 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
21130-186-78signature care nicotine1 in 1 BLISTER PACKGUM, CHEWING14
21130-186-78signature care nicotine100 in 1 CARTONGUM, CHEWING1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-186SIGNATURE CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAFEWAY]4Current NDC, Legacy NDC, 2 package rows20250321_da824d13-9dfa-41e5-a6ac-0081f5de74a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNda824d13-9dfa-41e5-a6ac-0081f5de74a84
314119nicotine 2 MG Chewing GumSCDda824d13-9dfa-41e5-a6ac-0081f5de74a84
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYda824d13-9dfa-41e5-a6ac-0081f5de74a84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-186-7821130018678100 BLISTER PACK in 1 CARTON (21130-186-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2018-08-270000-00-00NoNoCurrent