FDA.reportPublic FDA data

Gracie Square Hospital Amenity

Product NDC
59448-101
11-digit product format
594480101
Labeler code
59448
Product ID
59448-101_baaa5bdf-c58a-4b39-a6a6-dda6d98229fa
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
KIT
Labeler
ASP Global, LLc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-18
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gracie Square Hospital Amenity
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59448-101-002025-12-30C16284748780-1d6a99b39-ec40-a426-e053-dadaa90af4c2Gracie Square Hospital Amenity Kit
59448-101-002022-01-28C16284748780-1d6a99b39-ec40-a426-e053-dadaa90af4c2Gracie Square Hospital Amenity Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-101-00Gracie Square Hospital Amenity1 in 1 BAGKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-101GRACIE SQUARE HOSPITAL AMENITY (SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]5Current NDC, Legacy NDC, 1 package rows20190917_89d81053-6950-465e-a5b1-cbf841d7afcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN89d81053-6950-465e-a5b1-cbf841d7afcb6
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD89d81053-6950-465e-a5b1-cbf841d7afcb6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY89d81053-6950-465e-a5b1-cbf841d7afcb6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY89d81053-6950-465e-a5b1-cbf841d7afcb6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY89d81053-6950-465e-a5b1-cbf841d7afcb6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY89d81053-6950-465e-a5b1-cbf841d7afcb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-101-00594480101001 KIT in 1 BAG (59448-101-00) * 10 g in 1 TUBE (42555-060-45) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE1 kit2016-01-180000-00-00NoNoCurrent