FDA.reportPublic FDA data

59726-499-00

Product NDC
59726-499
Requested package NDC
59726-499-00
11-digit product format
597260499
Labeler code
59726
Product ID
59726-499_9932207d-beb3-4658-ac56-022eaf99b10e
Type
BULK INGREDIENT
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Marketing category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start
2024-10-22
Substance
NICOTINE
Active strength
2 mg/1
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage59726-49959726-499-00UNFINISHEDActive or certified unfinished drug listing2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-499NICOTINE POLACRILEX GUM, CHEWING [P & L DEVELOPMENT, LLC]2Unmatched20241024_4a8b7abc-bec9-414a-a362-8da140ead674.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
59726-499-00597260499001 BAG in 1 DRUM (59726-499-00) / 947917 GUM, CHEWING in 1 BAG1 bag22-OCT-24Current