FDA.reportPublic FDA data

Nicotine Mini

Product NDC
79903-127
11-digit product format
799030127
Labeler code
79903
Product ID
79903-127_4ca42e47-af7c-4316-a745-c0d9103e2591
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
WALMART INC. (see also Equate)
Application
ANDA207868
Marketing category
ANDA
Marketing start
2022-07-01
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
Nicotine Mini
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

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
79903-127-08Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE277
79903-127-08Nicotine Mini4 in 1 BOXLOZENGE47
79903-127-27Nicotine Mini1 in 1 BOXLOZENGE17
79903-127-27Nicotine Mini27 in 1 BOTTLE, PLASTICLOZENGE277

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-127NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [WALMART INC. (SEE ALSO EQUATE)]7Current NDC, Legacy NDC, 4 package rows20240605_b49546cd-6cc4-422c-9a72-3a1faf2abcd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNb49546cd-6cc4-422c-9a72-3a1faf2abcd37
359817nicotine 2 MG Oral LozengeSCDb49546cd-6cc4-422c-9a72-3a1faf2abcd37
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYb49546cd-6cc4-422c-9a72-3a1faf2abcd37
359817nicotine 2 MG TrocheSYb49546cd-6cc4-422c-9a72-3a1faf2abcd37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79903-127-08799030127084 BOTTLE, PLASTIC in 1 BOX (79903-127-08) / 27 LOZENGE in 1 BOTTLE, PLASTIC2022-07-010000-00-00NoNoCurrent
79903-127-27799030127271 BOTTLE, PLASTIC in 1 BOX (79903-127-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2022-07-010000-00-00NoNoCurrent