Home NDC 82091-116 KAYLAAN
Product NDC 82091-116
11-digit product format 820910116
Labeler code 82091
Product ID 82091-116_2b490a08-149f-76ab-e063-6394a90a084f
Type HUMAN OTC DRUG
Nonproprietary name Zero Waste Refill For Toothpaste
Dosage form TABLET, CHEWABLE
Route DENTAL
Labeler Kaylaan LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-13
Substance SODIUM FLUORIDE
Active strength .37 mg/440mg
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base KAYLAAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .37 mg/440mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82091-116-01 KAYLAAN 74.3 mg in 1 BOX, UNIT-DOSE TABLET, CHEWABLE 74.3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82091-116 KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250112_cb7f5f9b-4192-15e6-e053-2995a90a6457.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 29 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82091-116-01 82091011601 74.3 mg in 1 BOX, UNIT-DOSE (82091-116-01) 74.3 mg 2021-09-13 0000-00-00 No No Current