Home NDC 82091-116-01 KAYLAAN
Product NDC 82091-116
Requested package NDC 82091-116-01
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 26 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 39f64f10-f442-45a9-a060-9f99e78c678d 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. ed5a294a-fc03-43dd-825d-23a232060900 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. be558e5b-cf35-4035-a69c-8d66deeac6b2 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. a2591a96-ed66-45b1-abf6-6b26d0bb4f44 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. efe92e48-5086-4b61-a298-0d8ceefe100e 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f7862ee9-117a-493d-83ee-5aef588a86de 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 011c6a04-a489-41a5-ad2f-8ec281e07933 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 45422b0f-f1ac-4bec-851a-c1394bc52fcc 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c336f-60e3-dc23-e063-6294a90a4b13 2025-01-08 Warnings Exact identifier application number: M022
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