Home NDC 53942-435 Glowing White
Product NDC 53942-435
11-digit product format 539420435
Labeler code 53942
Product ID 53942-435_49f0a50b-0413-6830-e063-6394a90a5404
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler Demoulas Super Markets, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-29
Substance SODIUM FLUORIDE
Active strength .1 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Glowing White
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .1 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313029 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53942-435-45 Glowing White 946 mL in 1 BOTTLE, PLASTIC MOUTHWASH 946 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 HYDROGEN PEROXIDE INACTIVE INGREDIENT BBX060AN9V GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53942-435 GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC] 13 Current NDC, Legacy NDC, 1 package rows 20250418_32faf47d-b64f-4454-9f14-51503504c6b5.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 49 · 974 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53942-435-45 53942043545 946 mL in 1 BOTTLE, PLASTIC (53942-435-45) 946 ml 2015-07-29 0000-00-00 No No Current