FDA.reportPublic FDA data

Rexall Nicotine

Product NDC
55910-957
11-digit product format
559100957
Labeler code
55910
Product ID
55910-957_b1a961d6-357a-415e-94f2-a063b3021943
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-08-08
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
Rxcui359818

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
55910-957-60Rexall Nicotine20 in 1 CONTAINERLOZENGE205
55910-957-60Rexall Nicotine1 in 1 CARTONLOZENGE15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
NICOTINEACTIVE MOIETY6M3C89ZY6RREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9REXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49REXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4REXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-957REXALL NICOTINE (NICOTINE POLACRILEX) LOZENGE [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 2 package rows20220106_83b053f6-304b-4f9c-8a6d-6649998708b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN83b053f6-304b-4f9c-8a6d-6649998708b25
359818nicotine 4 MG Oral LozengeSCD83b053f6-304b-4f9c-8a6d-6649998708b25
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY83b053f6-304b-4f9c-8a6d-6649998708b25
359818nicotine 4 MG TrocheSY83b053f6-304b-4f9c-8a6d-6649998708b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-957-60559100957601 CONTAINER in 1 CARTON (55910-957-60) / 20 LOZENGE in 1 CONTAINER1 container2013-08-080000-00-00NoNoCurrent