FDA.reportPublic FDA data

Nauzene

Product NDC
52389-172
11-digit product format
523890172
Labeler code
52389
Product ID
52389-172_b35b5e0f-9b2e-40ae-9db7-65f245e40844
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Citrate
Dosage form
SYRUP
Route
ORAL
Labeler
Alva-Amco Pharmacal Companies, Inc.
Application
part357
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2000-02-15
Marketing end
0000-00-00
Substance
TRISODIUM CITRATE DIHYDRATE; DEXTROSE; FRUCTOSE
Active strength
1 g/15mL; g/15mL; g/15mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52389-172-042020-01-31C16284748780-19d75b9cf-d79c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-172-04Nauzene118 mL in 1 BOTTLE, PLASTICSYRUP1182

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DextroseACTIVE INGREDIENTIY9XDZ35W2NAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
FructoseACTIVE INGREDIENT6YSS42VSEVNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95KNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
DextroseACTIVE MOIETYIY9XDZ35W2NAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
FructoseACTIVE MOIETY6YSS42VSEVNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
corn syrupINACTIVE INGREDIENT9G5L16BK6NNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOANAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
High fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6SNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
Phosphoric acidINACTIVE INGREDIENTE4GA8884NNNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RNAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-172NAUZENE (SODIUM CITRATE) SYRUP [ALVA-AMCO PHARMACAL COMPANIES, INC.]2Legacy NDC, 1 package rows20100507_728376f5-6cab-404e-b519-f6c595291d6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895045glucose 4.35 GM / fructose 4.17 GM / sodium citrate 0.921 GM in 15 mL Oral SolutionPSN728376f5-6cab-404e-b519-f6c595291d6f2
895045fructose 278 MG/ML / glucose 290 MG/ML / sodium citrate 61.4 MG/ML Oral SolutionSCD728376f5-6cab-404e-b519-f6c595291d6f2
895045fructose 4.17 GM / glucose 4.35 GM / sodium citrate 0.921 GM per 15 ML Oral SolutionSY728376f5-6cab-404e-b519-f6c595291d6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52389-172-0452389017204118 mL in 1 BOTTLE, PLASTIC118 mlHistorical