Home NDC 81275-010 Rorobell WaWa Tooth
Product NDC 81275-010
11-digit product format 812750010
Labeler code 81275
Product ID 81275-010_5821995e-620b-385b-e063-6294a90a5c97
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler ROROBELL
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-01
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .72 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 Tooth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .72 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2471311 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81275-010-01 Rorobell WaWa Tooth 100 g in 1 TUBE PASTE, DENTIFRICE 100 4 81275-010-02 Rorobell WaWa Tooth 1 in 1 CARTON PASTE, DENTIFRICE 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81275-010 ROROBELL WAWA TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROROBELL] 3 Current NDC, Legacy NDC, 2 package rows 20241210_93113481-ad9d-4be0-a7b7-a72c8726127d.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 81275-010-01 81275001001 100 g in 1 TUBE 100 g Historical 81275-010-02 81275001002 1 TUBE in 1 CARTON (81275-010-02) / 100 g in 1 TUBE (81275-010-01) 1 tube 2020-12-01 0000-00-00 No No Current