Home NDC 62007-835-16 PCXX ANTICARIES NO FLAVOR NE G
Product NDC 62007-835
Requested package NDC 62007-835-16
11-digit product format 620070835
Labeler code 62007
Product ID 62007-835_3dfe9069-5287-412c-e063-6394a90aaaa7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL
Route DENTAL; TOPICAL
Labeler Ross Healthcare Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2019-02-23
Substance SODIUM FLUORIDE
Active strength 11.1 mg/mL
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 PCXX ANTICARIES NO FLAVOR NE G
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 11.1 mg/mL
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 1486566 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 62007-835-16 PCXX ANTICARIES NO FLAVOR NE G 473 mL in 1 BOTTLE, PLASTIC GEL 473 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62007-835 PCXX ANTICARIES NO FLAVOR NE G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250201_8296923b-a0a9-3bc8-e053-2991aa0a015a.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 1 of 1 · 1 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 62007-835-16 62007083516 473 mL in 1 BOTTLE, PLASTIC (62007-835-16) 473 ml 2019-02-23 0000-00-00 No No Current