FDA.reportPublic FDA data

PCXX BUGGLEGUM NEUTRAL GL

Product NDC
62007-126
Requested package NDC
62007-126-16
11-digit product format
620070126
Labeler code
62007
Product ID
62007-126_ba3dc6df-55d9-8ad1-e053-2a95a90a71b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
TOPICAL
Labeler
Ross Healthcare Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-11-17
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62007-12662007-126-16EExcluded after deficient or non-compliant submission was not corrected2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62007-12662007-126-16EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-126-162021-01-31C16284748780-1ba0f9c33-1a5d-a910-e053-dadaa90a0b85PCXX BUBBLEGUM NEUTRAL GEL
62007-126-162021-01-29C16284748780-1ba0f9c33-1a5d-a910-e053-dadaa90a0b85PCXX BUBBLEGUM NEUTRAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-126-16PCXX BUGGLEGUM NEUTRAL GL473 g in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-126PCXX BUGGLEGUM NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]6Legacy NDC, 1 package rows20250201_5e39590d-c15b-e645-e053-2a91aa0afd27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN5e39590d-c15b-e645-e053-2a91aa0afd276
245593sodium fluoride 0.02 MG/MG Oral GelSCD5e39590d-c15b-e645-e053-2a91aa0afd276
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY5e39590d-c15b-e645-e053-2a91aa0afd276
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY5e39590d-c15b-e645-e053-2a91aa0afd276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-126-1662007012616473 g in 1 BOTTLE, PLASTIC (62007-126-16) 473 g2017-11-170000-00-00NoNoCurrent