Home NDC 11527-045 Tanners Tasty Ooh La La Orange
Product NDC 11527-045
11-digit product format 115270045
Labeler code 11527
Product ID 11527-045_56115203-3364-4196-b1be-6ed903284864
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route ORAL
Labeler Sheffield Pharmaceuticals LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-25
Substance SODIUM FLUORIDE
Active strength 2.43 mg/g
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 Tanners Tasty Ooh La La Orange
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.43 mg/g
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 891775 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 11527-045-42 Tanners Tasty Ooh La La Orange 119 g in 1 TUBE PASTE, DENTIFRICE 119 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-045 TANNERS TASTY OOH LA LA ORANGE (SODIUM FLUORIDE) PASTE, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231025_6027b961-314e-4f71-8b2f-646ce80214d8.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 51 · 1,013 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 11527-045-42 11527004542 119 g in 1 TUBE (11527-045-42) 119 g 2021-03-25 0000-00-00 No No Current