FDA.reportPublic FDA data

Equate nicotine

Product NDC
49035-352
11-digit product format
490350352
Labeler code
49035
Product ID
49035-352_bcca6a4f-4719-481b-b45b-a530cdfb50d1
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA078547
Marketing category
ANDA
Marketing start
2008-10-14
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
Equate nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
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
49035-352-06Equate nicotine160 in 1 CARTONGUM, CHEWING16011
49035-352-06Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING111
49035-352-20Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING111
49035-352-20Equate nicotine200 in 1 CARTONGUM, CHEWING20011
49035-352-60Equate nicotine20 in 1 CARTONGUM, CHEWING2011
49035-352-60Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING111
49035-352-76Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING111
49035-352-76Equate nicotine120 in 1 CARTONGUM, CHEWING12011
49035-352-78Equate nicotine1 in 1 BLISTER PACKGUM, CHEWING111
49035-352-78Equate nicotine100 in 1 CARTONGUM, CHEWING10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-352-06EA - Each49035-352b2b77842-fade-4aeb-94e5-4ce4b5fbb7b212024-07-12
49035-352-78EA - Each49035-352f864c27a-3c4b-4502-ae64-523e6a605b6b12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
NICOTINEACTIVE MOIETY6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
GELATININACTIVE INGREDIENT2G86QN327LEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-352EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]10Current NDC, Legacy NDC, 10 package rows20250328_189c13db-b4b7-4534-ae3c-1c52bb879e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN189c13db-b4b7-4534-ae3c-1c52bb879e2b11
314119nicotine 2 MG Chewing GumSCD189c13db-b4b7-4534-ae3c-1c52bb879e2b11
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY189c13db-b4b7-4534-ae3c-1c52bb879e2b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-352-0649035035206160 BLISTER PACK in 1 CARTON (49035-352-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-08-080000-00-00NoNoCurrent
49035-352-2049035035220200 BLISTER PACK in 1 CARTON (49035-352-20) / 1 GUM, CHEWING in 1 BLISTER PACK200 blister pack2025-08-22NoNoCurrent
49035-352-604903503526020 BLISTER PACK in 1 CARTON (49035-352-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-08-080000-00-00NoNoCurrent
49035-352-76490350352761 in 1 BLISTER PACKHistorical
49035-352-7849035035278100 BLISTER PACK in 1 CARTON (49035-352-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2008-10-140000-00-00NoNoCurrent