FDA.reportPublic FDA data

equate Nicotine

Product NDC
49035-442
11-digit product format
490350442
Labeler code
49035
Product ID
49035-442_7222084a-ad08-40e6-a61d-d1d9354442f0
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091354
Marketing category
ANDA
Marketing start
1990-06-15
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-442-06equate Nicotine160 in 1 CARTONGUM, CHEWING16010
49035-442-06equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-442-20equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-442-20equate Nicotine200 in 1 CARTONGUM, CHEWING20010
49035-442-60equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-442-60equate Nicotine20 in 1 CARTONGUM, CHEWING2010
49035-442-76equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
49035-442-76equate Nicotine120 in 1 CARTONGUM, CHEWING12010
49035-442-78equate Nicotine100 in 1 CARTONGUM, CHEWING10010
49035-442-78equate Nicotine1 in 1 BLISTER PACKGUM, CHEWING110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-442-06EA - Each49035-442009dd0a3-cd72-4696-9f32-4c72033248dd12019-06-19
49035-442-60EA - Each49035-442a66fced4-1c63-4371-bc5c-7f299585c28812019-10-07
49035-442-78EA - Each49035-4427aa1ddeb-5a03-4543-900e-f45a1aeceb3212013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
NICOTINEACTIVE MOIETY6M3C89ZY6REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
ACACIAINACTIVE INGREDIENT5C5403N26OEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
MALTITOLINACTIVE INGREDIENTD65DG142WKEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3AEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-442EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC]9Current NDC, Legacy NDC, 10 package rows20241027_174c342d-898e-4d16-a688-5184a1ae409f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN174c342d-898e-4d16-a688-5184a1ae409f10
311975nicotine 4 MG Chewing GumSCD174c342d-898e-4d16-a688-5184a1ae409f10
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY174c342d-898e-4d16-a688-5184a1ae409f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-442-0649035044206160 BLISTER PACK in 1 CARTON (49035-442-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-08-080000-00-00NoNoCurrent
49035-442-2049035044220200 BLISTER PACK in 1 CARTON (49035-442-20) / 1 GUM, CHEWING in 1 BLISTER PACK200 blister pack2025-08-22NoNoCurrent
49035-442-604903504426020 BLISTER PACK in 1 CARTON (49035-442-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-08-080000-00-00NoNoCurrent
49035-442-76490350442761 in 1 BLISTER PACKHistorical
49035-442-7849035044278100 BLISTER PACK in 1 CARTON (49035-442-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2011-10-070000-00-00NoNoCurrent