Home NDC 44038-0687 Hello Unicorn Splash
Product NDC 44038-0687
11-digit product format 440380687
Labeler code 44038
Product ID 44038-0687_48fd0b79-d03d-113f-e063-6294a90a7e7f
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form MOUTHWASH
Route DENTAL
Labeler Accupac LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance SODIUM FLUORIDE
Active strength .02 g/100mL
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 Hello Unicorn Splash
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .02 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44038-0687-1 Hello Unicorn Splash 473 mL in 1 BOTTLE MOUTHWASH 473 3 44038-0687-2 Hello Unicorn Splash 520 mL in 1 BOTTLE MOUTHWASH 520 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 5 of 50 · 995 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 44038-0687-1 44038068701 473 mL in 1 BOTTLE (44038-0687-1) 473 ml 2023-07-01 2027-11-30 No No Historical 44038-0687-2 44038068702 520 mL in 1 BOTTLE (44038-0687-2) 520 ml 2026-01-01 No No Current