Home NDC 81275-011 ROROBELL WAWA Gum Care Tooth
Product NDC 81275-011
11-digit product format 812750011
Labeler code 81275
Product ID 81275-011_582204ef-b785-0d95-e063-6394a90a38d2
Type HUMAN OTC DRUG
Nonproprietary name Hydrated Silica, Sodium Fluoride, Tocopheryl Acetate
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler ROROBELL
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-08-01
Substance HYDRATED SILICA; SODIUM FLUORIDE; .ALPHA.-TOCOPHEROL ACETATE
Active strength 19; .32; .05 g/100g; g/100g; g/100g
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 ROROBELL WAWA Gum Care Tooth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRATED SILICA 19 g/100g SODIUM FLUORIDE .32 g/100g .ALPHA.-TOCOPHEROL ACETATE .05 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y6O7T4G8P9 Internal UNII lookup 8ZYQ1474W7 Internal UNII lookup 9E8X80D2L0 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81275-011-02 81275001102 1 TUBE in 1 CARTON (81275-011-02) / 100 g in 1 TUBE (81275-011-01) 1 tube 2026-08-01 No No Current