Home NDC 53208-568 EUTHYMOL WHITENING SET
Product NDC 53208-568
11-digit product format 532080568
Labeler code 53208
Product ID 53208-568_358399ee-bc12-06a1-e063-6394a90a9d96
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form KIT
Route DENTAL
Labeler LG HOUSEHOLD & HEALTH CARE LTD.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-09
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 EUTHYMOL WHITENING SET
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm 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 53208-566-63 EUTHYMOL WHITENING SET 106 g in 1 TUBE PASTE, DENTIFRICE 424 g in 4 1.5 mg in 1g 3 53208-566-65 EUTHYMOL WHITENING SET 4 in 1 CARTON PASTE, DENTIFRICE 1.5 mg in 1g 3 53208-566-73 EUTHYMOL WHITENING SET 70 g in 1 TUBE PASTE, DENTIFRICE 70 g 1.5 mg in 1g 3 53208-566-75 EUTHYMOL WHITENING SET 1 in 1 CARTON PASTE, DENTIFRICE 1.5 mg in 1g 3 53208-568-00 EUTHYMOL WHITENING SET 1 in 1 CARTON KIT 1 3
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 34 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dentisse SODIUM FLUORIDE Dentisse, Inc. 326b290a-9bd2-468e-e054-00144ff8d46c 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 51f1d84c-809a-4c96-a117-7a8d8aa1e6b4 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. c44686f8-93ee-4a8f-8481-3439d123f6d2 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 16ebcb37-5703-4e10-b965-570e18434b52 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker GREAT WHITE SHARK SODIUM FLUORIDE YOUNG PS ACQUISITION, LLC ca5b91aa-f69c-4553-a2b6-acf0ca1d920e 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65fa41e-ce2e-53e4-e053-2995a90a24d2 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65c62d9-e8a6-3101-e053-2995a90a1494 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75 2025-11-04 Warnings Exact identifier application number: M021 Strawberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426c2aca-ca2b-5e34-e063-6294a90ae37c 2025-11-02 Warnings Exact identifier application number: M021 Watermelon Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426e40cb-e30d-0db1-e063-6294a90a762b 2025-10-31 Warnings Exact identifier application number: M021 Classic Mint Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425a9b71-5a7f-83e6-e063-6394a90ab703 2025-10-30 Warnings Exact identifier application number: M021 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425b1a2e-7576-13a7-e063-6394a90aa865 2025-10-30 Warnings Exact identifier application number: M021 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426b8efa-e691-a67d-e063-6394a90abf8d 2025-10-30 Warnings Exact identifier application number: M021 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 42583b32-525f-925d-e063-6294a90af76f 2025-10-29 Warnings Exact identifier application number: M021 PERIOE KAKAO KIDS Strawberry SODIUM FLUORIDE LG HOUSEHOLD & HEALTH CARE LTD. 4239f8c2-a5f5-3fa6-e063-6294a90acb47 2025-10-28 Warnings Exact identifier application number: M021 Gerigentle-Good morning SODIUM FLORIDE Geri-Gentle Corporation e69b3767-00c5-a535-e053-2995a90ad215 2025-10-23 Warnings Exact identifier application number: M021 Hello Penguin Chill SODIUM FLUORIDE Colgate-Palmolive Company 5c47a7d5-da34-4658-8006-b36f6477cb9b 2025-10-23 Warnings Exact identifier application number: M021 Auraglow Whitening SODIUM FLUORIDE Auraglow LLC 9d45e436-92f6-4a9e-9b82-329847dca9ba 2025-10-22 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3 2025-10-21 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Qubec Inc. DBA Attitude de21b326-f885-464b-b2df-f3866a0b3e9a 2025-10-20 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53208-566-63 53208056663 106 g in 1 TUBE 106 g Historical 53208-566-65 53208056665 4 in 1 CARTON Historical 53208-566-73 53208056673 70 g in 1 TUBE 70 g Historical 53208-566-75 53208056675 1 in 1 CARTON Historical 53208-568-00 53208056800 1 KIT in 1 CARTON (53208-568-00) * 4 TUBE in 1 CARTON (53208-566-65) / 106 g in 1 TUBE (53208-566-63) * 1 TUBE in 1 CARTON (53208-566-75) / 70 g in 1 TUBE (53208-566-73) 1 kit 2025-06-09 No No Current