FDA.reportPublic FDA data

PCXX PEPPERMINT NEUTRAL F

Product NDC
62007-902
11-digit product format
620070902
Labeler code
62007
Product ID
62007-902_ba3d9d9b-2694-4a74-e053-2995a90aaaa0
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
2019-03-28
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 productproduct62007-902EExcluded after deficient or non-compliant submission was not corrected2026-10-05
excluded packagepackage62007-90262007-902-07EExcluded 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 · 2 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 productproduct62007-902EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62007-90262007-902-07EExcluded 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
62007-902-072021-01-31C16284748780-1ba0f9c33-436e-a910-e053-dadaa90a0b85PCXX PEPPERMINT NEUTRAL F
62007-902-072021-01-29C16284748780-1ba0f9c33-436e-a910-e053-dadaa90a0b85PCXX PEPPERMINT NEUTRAL F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-902-07PCXX PEPPERMINT NEUTRAL F125 g in 1 CANAEROSOL, FOAM1255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-902PCXX PEPPERMINT NEUTRAL F (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]5Legacy NDC, 1 package rows20250201_85a29824-0544-1411-e053-2a91aa0a451b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363558PCxx Neutral Foam 2 % Oral FoamPSN85a29824-0544-1411-e053-2a91aa0a451b5
688393sodium fluoride 2 % Oral FoamPSN85a29824-0544-1411-e053-2a91aa0a451b5
1363558sodium fluoride 20 MG/ML Oral Foam [PCxx Neutral Foam]SBD85a29824-0544-1411-e053-2a91aa0a451b5
688393sodium fluoride 20 MG/ML Oral FoamSCD85a29824-0544-1411-e053-2a91aa0a451b5
1363558PCxx Neutral Foam 2 % Oral FoamSY85a29824-0544-1411-e053-2a91aa0a451b5
1363558PCxx Neutral Foam 20 MG/ML Oral FoamSY85a29824-0544-1411-e053-2a91aa0a451b5
688393sodium fluoride 2 % Oral FoamSY85a29824-0544-1411-e053-2a91aa0a451b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-902-0762007090207125 g in 1 CAN (62007-902-07) 125 g2019-03-280000-00-00NoNoCurrent