FDA.reportPublic FDA data

PCXX WATERMELON APF G

Product NDC
62007-813
Requested package NDC
62007-813-16
11-digit product format
620070813
Labeler code
62007
Product ID
62007-813_4c11499d-25cf-e53a-e063-6394a90ad974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL; TOPICAL
Labeler
Ross Healthcare Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-02-22
Substance
SODIUM FLUORIDE
Active strength
27.2 mg/mL
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 packagepackage62007-81362007-813-16EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX WATERMELON APF G
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE27.2 mg/mL

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
1535362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8287b2de-028a-3eaa-e053-2a91aa0a0bd3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-813-162021-01-31C16284748780-1ba0f9c33-38c1-a910-e053-dadaa90a0b85PCXX WATERMELON APF GEL
62007-813-162021-01-29C16284748780-1ba0f9c33-38c1-a910-e053-dadaa90a0b85PCXX WATERMELON APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-813-16PCXX WATERMELON APF G473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-813PCXX WATERMELON APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_8287b2de-028a-3eaa-e053-2a91aa0a0bd3.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 WATERMELON APF GSODIUM FLUORIDERoss Healthcare Inc.8287b2de-028a-3eaa-e053-2a91aa0a0bd32026-03-02Exact identifier
ndc (package): 62007-813-16
ndc (product): 62007-813
ndc11 (package): 62007081316

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSN8287b2de-028a-3eaa-e053-2a91aa0a0bd36
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD8287b2de-028a-3eaa-e053-2a91aa0a0bd36
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY8287b2de-028a-3eaa-e053-2a91aa0a0bd36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-813-1662007081316473 mL in 1 BOTTLE, PLASTIC (62007-813-16) 473 ml2019-02-220000-00-00NoNoCurrent