Mini Nicotine

Product NDC
49035-436
11-digit product format
490350436
Labeler code
49035
Product ID
49035-436_1c22ae1e-28ce-436f-b143-830894974bf9
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA207868
Marketing category
ANDA
Marketing start
2021-01-15
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
Mini 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-436-08Mini Nicotine4 in 1 BOXLOZENGE44
49035-436-08Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE274
49035-436-27Mini Nicotine1 in 1 BOXLOZENGE14
49035-436-27Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-436MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]4Current NDC, Legacy NDC, 4 package rows20250131_9b1d9efc-f74b-42f5-be84-5142ee168767.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN9b1d9efc-f74b-42f5-be84-5142ee1687674
359818nicotine 4 MG Oral LozengeSCD9b1d9efc-f74b-42f5-be84-5142ee1687674
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY9b1d9efc-f74b-42f5-be84-5142ee1687674
359818nicotine 4 MG TrocheSY9b1d9efc-f74b-42f5-be84-5142ee1687674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-436-08490350436084 BOTTLE, PLASTIC in 1 BOX (49035-436-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-01-150000-00-00NoNoCurrent
49035-436-27490350436271 BOTTLE, PLASTIC in 1 BOX (49035-436-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2021-01-150000-00-00NoNoCurrent