FDA.reportPublic FDA data

Nicotine

Product NDC
30142-873
11-digit product format
301420873
Labeler code
30142
Product ID
30142-873_1c7b77a7-bf22-442b-b6fc-e52098604e63
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Kroger Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2007-04-27
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
Rxcui359818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-873-05Nicotine24 in 1 CONTAINERLOZENGE247
30142-873-05Nicotine3 in 1 CARTONLOZENGE37
30142-873-06Nicotine4 in 1 CARTONLOZENGE47
30142-873-06Nicotine24 in 1 CONTAINERLOZENGE247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-873-05EA - Each30142-8732df32937-09ce-499d-a4c2-8f719a3ea67d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-873NICOTINE (NICOTINE POLACRILEX) LOZENGE [KROGER COMPANY]7Current NDC, Legacy NDC, 4 package rows20190411_35f45900-af2e-4b74-9772-8beb55236457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN35f45900-af2e-4b74-9772-8beb552364577
359818nicotine 4 MG Oral LozengeSCD35f45900-af2e-4b74-9772-8beb552364577
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY35f45900-af2e-4b74-9772-8beb552364577
359818nicotine 4 MG TrocheSY35f45900-af2e-4b74-9772-8beb552364577

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-873-05301420873053 CONTAINER in 1 CARTON (30142-873-05) / 24 LOZENGE in 1 CONTAINER3 container2009-09-230000-00-00NoNoCurrent
30142-873-06301420873064 CONTAINER in 1 CARTON (30142-873-06) / 24 LOZENGE in 1 CONTAINER4 container2016-07-270000-00-00NoNoCurrent