Home NDC 62007-827-16 PCXX WATERMELON NEUTRAL GL
Product NDC 62007-827
Requested package NDC 62007-827-16
11-digit product format 620070827
Labeler code 62007
Product ID 62007-827_4c116a64-da34-d446-e063-6294a90a4a51
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 2019-02-22
Substance SODIUM FLUORIDE
Active strength 20 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62007-827 62007-827-16 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Additional Listing Data#
Finished product Yes
Brand name base PCXX WATERMELON NEUTRAL GL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 20 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 245593 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 62007-827-16 PCXX WATERMELON NEUTRAL GL 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 62007-827 PCXX WATERMELON NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250201_829ac847-27d7-6461-e053-2991aa0a5e9a.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 62007-827-16 62007082716 473 mL in 1 BOTTLE, PLASTIC (62007-827-16) 473 ml 2019-02-22 0000-00-00 No No Current