PCXX PEPPERMINT APF F

Product NDC
62007-059
Requested package NDC
62007-059-07
11-digit product format
620070059
Labeler code
62007
Product ID
62007-059_3a777df2-0ece-8799-e063-6294a90a3105
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
2017-11-21
Substance
SODIUM FLUORIDE
Active strength
.0272 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05EExcluded after deficient or non-compliant submission was not correctedd630ba8d3edf…732f749b63fb…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX PEPPERMINT APF F
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.0272 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248389Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e86783c-414a-5f46-e053-2991aa0abb3bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-02-12PCXX PEPPERMINT APF F
2025-01-30PCXX PEPPERMINT APF F
2021-01-31PCXX PEPPERMINT APF F
2021-01-29PCXX PEPPERMINT APF F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-059-07PCXX PEPPERMINT APF F125 g in 1 CANAEROSOL, FOAM1256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-059PCXX PEPPERMINT APF F (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250214_5e86783c-414a-5f46-e053-2991aa0abb3b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PCXX PEPPERMINT APF FSODIUM FLUORIDERoss Healthcare Inc.5e86783c-414a-5f46-e053-2991aa0abb3b2025-07-21Exact identifier
ndc (package): 62007-059-07
ndc (product): 62007-059
ndc11 (package): 62007005907

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248389sodium fluoride 2.72 % Oral FoamPSN5e86783c-414a-5f46-e053-2991aa0abb3b6
248389sodium fluoride 27.2 MG/ML Oral FoamSCD5e86783c-414a-5f46-e053-2991aa0abb3b6
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY5e86783c-414a-5f46-e053-2991aa0abb3b6
248389sodium fluoride 2.72 % Oral FoamSY5e86783c-414a-5f46-e053-2991aa0abb3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-059-0762007005907125 g in 1 CAN (62007-059-07) 125 g2017-11-210000-00-00NoNoCurrent