PCXX RASPBERRY APF G

Product NDC
62007-809
11-digit product format
620070809
Labeler code
62007
Product ID
62007-809_ba3dccee-b4d7-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
2019-02-04
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62007-809DDiscontinued by firm2026-09-14
excluded packagepackage62007-80962007-809-16DDiscontinued by firm2026-09-14

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62007-809-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62007-809-16f5e01cc5f278…a2eaf40c39c3…

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
62007-809-162021-01-31C16284748780-1ba0f9c33-1ae7-a910-e053-dadaa90a0b85PCXX RASPBERRY APF GEL
62007-809-162021-01-29C16284748780-1ba0f9c33-1ae7-a910-e053-dadaa90a0b85PCXX RASPBERRY APF GEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-809PCXX RASPBERRY APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]6Legacy NDC20250201_8281515f-08ab-509c-e053-2a91aa0abae3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-809-1662007080916473 mL in 1 BOTTLE, PLASTIC (62007-809-16) 473 ml2019-02-040000-00-00NoNoCurrent