FDA.reportPublic FDA data

Equate Nicotine

Product NDC
49035-854
11-digit product format
490350854
Labeler code
49035
Product ID
49035-854_f2bd842e-1342-4101-a2f7-6f64af9d99ec
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA078546
Marketing category
ANDA
Marketing start
2008-10-14
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
Equate Nicotine
Listing expiration
2026-12-31

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
49035-854-06Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-854-06Equate Nicotine160 in 1 CARTONGUM, CHEWING16012
49035-854-20Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-854-20Equate Nicotine200 in 1 CARTONGUM, CHEWING20012
49035-854-60Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-854-60Equate Nicotine20 in 1 CARTONGUM, CHEWING2012
49035-854-76Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
49035-854-76Equate Nicotine120 in 1 CARTONGUM, CHEWING12012
49035-854-78Equate Nicotine100 in 1 CARTONGUM, CHEWING10012
49035-854-78Equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-854-78EA - Each49035-85489c5508b-b77d-4aee-bdc8-c08043f8952112013-06-04

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
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUATE 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
49035-854EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]11Current NDC, Legacy NDC, 10 package rows20250331_54c1a1d5-f7b4-4109-8887-02dc10bfd593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN54c1a1d5-f7b4-4109-8887-02dc10bfd59312
311975nicotine 4 MG Chewing GumSCD54c1a1d5-f7b4-4109-8887-02dc10bfd59312
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY54c1a1d5-f7b4-4109-8887-02dc10bfd59312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-854-0649035085406160 BLISTER PACK in 1 CARTON (49035-854-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-08-100000-00-00NoNoCurrent
49035-854-2049035085420200 BLISTER PACK in 1 CARTON (49035-854-20) / 1 GUM, CHEWING in 1 BLISTER PACK200 blister pack2025-08-22NoNoCurrent
49035-854-604903508546020 BLISTER PACK in 1 CARTON (49035-854-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-09-260000-00-00NoNoCurrent
49035-854-76490350854761 in 1 BLISTER PACKHistorical
49035-854-7849035085478100 BLISTER PACK in 1 CARTON (49035-854-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2008-10-140000-00-00NoNoCurrent