FDA.reportPublic FDA data

Rexall Nicotine

Product NDC
55910-532
11-digit product format
559100532
Labeler code
55910
Product ID
55910-532_2d8aee56-ab8d-4e1a-a568-dd355ae69b5a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA076779
Marketing category
ANDA
Marketing start
2011-05-17
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
Rexall 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
55910-532-60Rexall Nicotine20 in 1 CARTONGUM, CHEWING207
55910-532-60Rexall Nicotine1 in 1 BLISTER PACKGUM, CHEWING17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
NICOTINEACTIVE MOIETY6M3C89ZY6RREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
GELATININACTIVE INGREDIENT2G86QN327LREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EREXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-532REXALL NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, LLC]7Current NDC, Legacy NDC, 2 package rows20210515_d5921224-43c1-4726-ba61-180ea79423b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNd5921224-43c1-4726-ba61-180ea79423b67
311975nicotine 4 MG Chewing GumSCDd5921224-43c1-4726-ba61-180ea79423b67
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYd5921224-43c1-4726-ba61-180ea79423b67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-532-605591005326020 BLISTER PACK in 1 CARTON (55910-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2011-05-170000-00-00NoNoCurrent