FDA.reportPublic FDA data

nicotine

Product NDC
11822-0309
11-digit product format
118220309
Labeler code
11822
Product ID
11822-0309_f9d4016b-a08e-46d5-8078-a2ff63c4bff6
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
2017-01-24
Marketing end
2026-09-30
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
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
11822-0309-0nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0309-0nicotine10 in 1 CARTONGUM, CHEWING108
11822-0309-1nicotine20 in 1 CARTONGUM, CHEWING208
11822-0309-1nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0309-2nicotine100 in 1 CARTONGUM, CHEWING1008
11822-0309-2nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0309-3nicotine160 in 1 CARTONGUM, CHEWING1608
11822-0309-3nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0309-4nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0309-4nicotine120 in 1 CARTONGUM, CHEWING1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0309NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]7Current NDC, Legacy NDC, 10 package rows20250312_4dee260e-784b-40a3-aa79-579c36cfc82c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN4dee260e-784b-40a3-aa79-579c36cfc82c8
311975nicotine 4 MG Chewing GumSCD4dee260e-784b-40a3-aa79-579c36cfc82c8
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY4dee260e-784b-40a3-aa79-579c36cfc82c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0309-01182203090010 BLISTER PACK in 1 CARTON (11822-0309-0) > 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2017-09-060000-00-00NoNoCurrent
11822-0309-11182203090120 BLISTER PACK in 1 CARTON (11822-0309-1) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-01-242026-09-30NoNoCurrent
11822-0309-211822030902100 BLISTER PACK in 1 CARTON (11822-0309-2) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2017-01-242026-09-30NoNoCurrent
11822-0309-311822030903160 BLISTER PACK in 1 CARTON (11822-0309-3) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-01-242026-08-31NoNoCurrent
11822-0309-411822030904120 BLISTER PACK in 1 CARTON (11822-0309-4) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2017-05-030000-00-00NoNoCurrent