FDA.reportPublic FDA data

PCXX NEUTRAL RNS STRAWBERRY

Product NDC
62007-216
11-digit product format
620070216
Labeler code
62007
Product ID
62007-216_3dfeaa9b-c1ef-87cc-e063-6394a90a8240
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUORIDE TREATMENT
Dosage form
RINSE
Route
DENTAL; TOPICAL
Labeler
Ross Healthcare Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-03-20
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX NEUTRAL RNS STRAWBERRY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251960Internal RxNorm lookup
1600786Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14234397-211b-d30a-e063-6394a90a9db6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-216-64PCXX NEUTRAL RNS STRAWBERRY1900 g in 1 BOTTLE, PLASTICRINSE19003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-216PCXX NEUTRAL RNS STRAWBERRY (FLUORIDE TREATMENT) RINSE [ROSS HEALTHCARE INC.]1Current NDC, 1 package rows20240322_14234397-211b-d30a-e063-6394a90a9db6.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 NEUTRAL RNS STRAWBERRYFLUORIDE TREATMENTRoss Healthcare Inc.14234397-211b-d30a-e063-6394a90a9db62025-09-04WarningsExact identifier
ndc (product): 62007-216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600786PCxx Neutral Rinse 2 % MouthwashPSN14234397-211b-d30a-e063-6394a90a9db63
251960sodium fluoride 2 % Oral RinsePSN14234397-211b-d30a-e063-6394a90a9db63
1600786sodium fluoride 20 MG/ML Mouthwash [PCxx Neutral Rinse]SBD14234397-211b-d30a-e063-6394a90a9db63
251960sodium fluoride 20 MG/ML MouthwashSCD14234397-211b-d30a-e063-6394a90a9db63
1600786PCxx Neutral Rinse 2 % MouthwashSY14234397-211b-d30a-e063-6394a90a9db63
1600786PCxx Neutral Rinse 20 MG/ML MouthwashSY14234397-211b-d30a-e063-6394a90a9db63
251960sodium fluoride 2 % Oral RinseSY14234397-211b-d30a-e063-6394a90a9db63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62007-216-64620070216641900 g in 1 BOTTLE, PLASTIC (62007-216-64) 1900 g2024-03-20NoNoCurrent