FDA.reportPublic FDA data

PCXX VANILLA ORANGE APF G

Product NDC
62007-811
Requested package NDC
62007-811-16
11-digit product format
620070811
Labeler code
62007
Product ID
62007-811_ba3dccee-b4cd-a919-e053-2a95a90a5a2f
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
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
27 mg/mL
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 packagepackage62007-81162007-811-16EExcluded after deficient or non-compliant submission was not corrected2026-10-16

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 packagepackage62007-81162007-811-16EExcluded 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
62007-811-162021-01-31C16284748780-1ba0f9c33-5724-a910-e053-dadaa90a0b85PCXX VANILLA ORANGE APF GEL
62007-811-162021-01-29C16284748780-1ba0f9c33-5724-a910-e053-dadaa90a0b85PCXX VANILLA ORANGE APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-811-16PCXX VANILLA ORANGE APF G473 mL in 1 BOTTLE, PLASTICGEL4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-811PCXX VANILLA ORANGE APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Legacy NDC, 1 package rows20250201_82978289-494e-83b1-e053-2991aa0a6365.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSN82978289-494e-83b1-e053-2991aa0a63655
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD82978289-494e-83b1-e053-2991aa0a63655
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY82978289-494e-83b1-e053-2991aa0a63655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-811-1662007081116473 mL in 1 BOTTLE, PLASTIC (62007-811-16) 473 ml2019-02-220000-00-00NoNoCurrent