FDA.reportPublic FDA data

nicotine

Product NDC
11822-0971
11-digit product format
118220971
Labeler code
11822
Product ID
11822-0971_20ab08c5-72b6-49f4-944e-c08ff97cf4a3
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA206393
Marketing category
ANDA
Marketing start
2020-12-11
Marketing end
2026-10-31
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine

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
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
11822-0971-1nicotine1 in 1 BLISTER PACKGUM, CHEWING17
11822-0971-1nicotine20 in 1 CARTONGUM, CHEWING207
11822-0971-2nicotine1 in 1 BLISTER PACKGUM, CHEWING17
11822-0971-2nicotine160 in 1 CARTONGUM, CHEWING1607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0971NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]6Current NDC, Legacy NDC, 4 package rows20250315_9d315243-b55e-4277-b0c2-83e7b5fe504c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN9d315243-b55e-4277-b0c2-83e7b5fe504c7
311975nicotine 4 MG Chewing GumSCD9d315243-b55e-4277-b0c2-83e7b5fe504c7
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY9d315243-b55e-4277-b0c2-83e7b5fe504c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0971-11182209710120 BLISTER PACK in 1 CARTON (11822-0971-1) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2020-12-112026-10-31NoNoCurrent
11822-0971-211822097102160 BLISTER PACK in 1 CARTON (11822-0971-2) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2023-03-272026-10-31NoNoHistorical