FDA.reportPublic FDA data

PCXX VANILLA ORANGE ONE MINUTE FM

Product NDC
62007-051
11-digit product format
620070051
Labeler code
62007
Product ID
62007-051_4c4c9ea1-436e-b89b-e063-6394a90a5067
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
AEROSOL, FOAM
Route
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

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX VANILLA ORANGE ONE MINUTE FM
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
5e816186-519e-606e-e053-2a91aa0a3460Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-051-072021-01-31C16284748780-1ba0f9c33-1a60-a910-e053-dadaa90a0b85PCXX VANILLA ORANGE ONE MINUTE FM
62007-051-072021-01-29C16284748780-1ba0f9c33-1a60-a910-e053-dadaa90a0b85PCXX VANILLA ORANGE ONE MINUTE FM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-051-07PCXX VANILLA ORANGE ONE MINUTE FM125 g in 1 CANAEROSOL, FOAM12510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-051PCXX VANILLA ORANGE ONE MINUTE FM (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]8Current NDC, Legacy NDC, 1 package rows20250201_5e816186-519e-606e-e053-2a91aa0a3460.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 VANILLA ORANGE ONE MINUTE FMSODIUM FLUORIDERoss Healthcare Inc.5e816186-519e-606e-e053-2a91aa0a34602026-03-05Exact identifier
ndc (product): 62007-051

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248389sodium fluoride 2.72 % Oral FoamPSN5e816186-519e-606e-e053-2a91aa0a346010
248389sodium fluoride 27.2 MG/ML Oral FoamSCD5e816186-519e-606e-e053-2a91aa0a346010
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY5e816186-519e-606e-e053-2a91aa0a346010
248389sodium fluoride 2.72 % Oral FoamSY5e816186-519e-606e-e053-2a91aa0a346010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-051-0762007005107125 g in 1 CAN (62007-051-07) 125 g2017-11-210000-00-00NoNoCurrent