Home NDC 67933-0016 PerCara Kids Bubble Gum
Product NDC 67933-0016
11-digit product format 679330016
Labeler code 67933
Product ID 67933-0016_0eb3968a-ead0-c8c9-e063-6394a90a06e5
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form RINSE
Route ORAL
Labeler LEC Custom Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-23
Substance SODIUM FLUORIDE
Active strength .05 g/100mL
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 PerCara Kids Bubble Gum
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .05 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 67933-0016-1 PerCara Kids Bubble Gum 532 mL in 1 BOTTLE, PLASTIC RINSE 532 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67933-0016 PERCARA KIDS BUBBLE GUM (SODIUM FLUORIDE) RINSE [LEC CUSTOM PRODUCTS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240116_be3a7272-acfb-7d14-e053-2995a90a9420.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 5 of 50 · 995 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 67933-0016-1 67933001601 532 mL in 1 BOTTLE, PLASTIC (67933-0016-1) 532 ml 2021-03-23 0000-00-00 No No Current