PCXX STRAWBERRY APF F

Product NDC
62007-055
Requested package NDC
62007-055-07
11-digit product format
620070055
Labeler code
62007
Product ID
62007-055_4c4ce5e7-14e5-2236-e063-6294a90abe07
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 · 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 packagepackage62007-05562007-055-07EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX STRAWBERRY 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
5e859333-b798-2dd3-e053-2991aa0af2e3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-055-072021-01-31C16284748780-1ba0f9c33-573c-a910-e053-dadaa90a0b85PCXX STRAWBERRY APF F
62007-055-072021-01-29C16284748780-1ba0f9c33-573c-a910-e053-dadaa90a0b85PCXX STRAWBERRY APF F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-055-07PCXX STRAWBERRY APF F125 g in 1 CANAEROSOL, FOAM1257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-055PCXX STRAWBERRY APF F (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]6Current NDC, Legacy NDC, 1 package rows20250201_5e859333-b798-2dd3-e053-2991aa0af2e3.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 STRAWBERRY APF FSODIUM FLUORIDERoss Healthcare Inc.5e859333-b798-2dd3-e053-2991aa0af2e32026-03-05Exact identifier
ndc (package): 62007-055-07
ndc (product): 62007-055
ndc11 (package): 62007005507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248389sodium fluoride 2.72 % Oral FoamPSN5e859333-b798-2dd3-e053-2991aa0af2e37
248389sodium fluoride 27.2 MG/ML Oral FoamSCD5e859333-b798-2dd3-e053-2991aa0af2e37
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY5e859333-b798-2dd3-e053-2991aa0af2e37
248389sodium fluoride 2.72 % Oral FoamSY5e859333-b798-2dd3-e053-2991aa0af2e37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-055-0762007005507125 g in 1 CAN (62007-055-07) 125 g2017-11-210000-00-00NoNoCurrent