FDA.reportPublic FDA data

59726-428-00

Product NDC
59726-428
Requested package NDC
59726-428-00
11-digit product format
597260428
Labeler code
59726
Product ID
59726-428_e4531f3c-eba1-4a81-a394-c2485bbcfb01
Type
BULK INGREDIENT
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Marketing category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start
2024-11-30
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 packagepackage59726-42859726-428-00UNFINISHEDActive or certified unfinished drug listing2026-10-15

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
59726-428NICOTINE POLACRILEX GUM, CHEWING [P & L DEVELOPMENT, LLC]1Unmatched20241130_f3175d35-bfd1-4a75-b897-6916695ce6f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
59726-428-00597260428001 BAG in 1 DRUM (59726-428-00) / 947917 GUM, CHEWING in 1 BAG1 bag30-NOV-24Current