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Nicotine Polacrilex

Nicotine Polacrilex Gum Mint 2 mg and 4 mg - Walgreens

Approved
Approval ID

23ca9fd2-41a0-4210-ad97-62ec84d79907

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

Lucy Goods, Inc.

DUNS: 080875415

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nicotine Polacrilex

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72224-927
Application NumberANDA078699
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification

INGREDIENTS (11)

NICOTINEActive
Quantity: 2 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT

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Nicotine Polacrilex - FDA Drug Approval Details