Home NDC 35000-687 Hello Unicorn Splash
Product NDC 35000-687
11-digit product format 350000687
Labeler code 35000
Product ID 35000-687_5ad12666-22b6-4760-894f-8d9e96f41714
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form MOUTHWASH
Route DENTAL
Labeler Colgate-Palmolive Company
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
Brand name suffix unicorn splash anticavity fluoride rinse
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240698 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 35000-687-10 Hello Unicorn Splashunicorn splash anticavity fluoride rinse 473 mL in 1 BOTTLE MOUTHWASH 473 8 35000-687-12 Hello Unicorn Splashunicorn splash anticavity fluoride rinse 520 mL in 1 BOTTLE MOUTHWASH 520 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35000-687 HELLO UNICORN SPLASH UNICORN SPLASH ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [COLGATE-PALMOLIVE COMPANY] 7 Current NDC, 2 package rows 20250418_a1014431-7d23-aaff-6dc7-ab58683d0338.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 44 of 49 · 972 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 35000-687-10 35000068710 473 mL in 1 BOTTLE (35000-687-10) 473 ml 2023-07-01 No No Current 35000-687-12 35000068712 520 mL in 1 BOTTLE (35000-687-12) 520 ml 2026-01-01 No No Current