FDA.reportPublic FDA data

PCXX NO FLAVOR NEUTRAL F

Product NDC
62007-100
11-digit product format
620070100
Labeler code
62007
Product ID
62007-100_ba3dcc40-b332-d3f9-e053-2995a90a18de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
AEROSOL, FOAM
Route
DENTAL; TOPICAL
Labeler
Ross Healthcare Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-02-24
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 g/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62007-100DDiscontinued by firm2026-10-05
excluded packagepackage62007-10062007-100-07DDiscontinued by firm2026-10-05

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 · 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 packagepackage62007-100-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62007-100-07f5e01cc5f278…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
62007-100-072021-01-31C16284748780-1ba0f9c33-38dc-a910-e053-dadaa90a0b85PCXX NO FLAVOR NEUTRAL F
62007-100-072021-01-29C16284748780-1ba0f9c33-38dc-a910-e053-dadaa90a0b85PCXX NO FLAVOR NEUTRAL F

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-100PCXX NO FLAVOR NEUTRAL F (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]5Legacy NDC20250201_82b085a1-fd3e-1472-e053-2991aa0a2498.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-100-0762007010007125 g in 1 CAN (62007-100-07) 125 g2019-02-240000-00-00NoNoCurrent