Home NDC 37000-925 Burts Bees
Product NDC 37000-925
11-digit product format 370000925
Labeler code 37000
Product ID 37000-925_47e4ea72-0686-1933-e063-6294a90ad7e1
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Procter & Gamble Manufacturing Company
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-09
Substance SODIUM FLUORIDE
Active strength 1.3 mg/g
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 Burts Bees
Brand name suffix Extra White Zen Peppermint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.3 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37000-925-47 Burts BeesExtra White Zen Peppermint 1 in 1 CARTON PASTE, DENTIFRICE 1 7 37000-925-47 Burts BeesExtra White Zen Peppermint 133 g in 1 TUBE PASTE, DENTIFRICE 133 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37000-925 BURTS BEES EXTRA WHITE ZEN PEPPERMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY] 5 Current NDC, Legacy NDC, 2 package rows 20250110_81279e1f-6224-8114-e053-2991aa0aab08.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 37000-925-47 37000092547 1 TUBE in 1 CARTON (37000-925-47) / 133 g in 1 TUBE 1 tube 2019-01-09 0000-00-00 No No Current