PCXX MARSHMALLOW APF G

Product NDC
62007-805
11-digit product format
620070805
Labeler code
62007
Product ID
62007-805_4c1190d7-f177-0a50-e063-6294a90aa7c6
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
2019-02-04
Substance
SODIUM FLUORIDE
Active strength
27.2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1535362

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-805-162021-01-31C16284748780-1ba0f9c33-2f4f-a910-e053-dadaa90a0b85PCXX MARSHMALLOW APF GEL
62007-805-162021-01-29C16284748780-1ba0f9c33-2f4f-a910-e053-dadaa90a0b85PCXX MARSHMALLOW APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-805-16PCXX MARSHMALLOW APF G473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-805PCXX MARSHMALLOW APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_827459cc-faf2-3e7c-e053-2a91aa0aa480.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSN827459cc-faf2-3e7c-e053-2a91aa0aa4806
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD827459cc-faf2-3e7c-e053-2a91aa0aa4806
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY827459cc-faf2-3e7c-e053-2a91aa0aa4806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-805-1662007080516473 mL in 1 BOTTLE, PLASTIC (62007-805-16) 473 ml2019-02-040000-00-00NoNoCurrent