FDA.reportPublic FDA data

Nauzene

Product NDC
52389-242
11-digit product format
523890242
Labeler code
52389
Product ID
52389-242_2d7c94e6-382b-1655-e063-6394a90a712d
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Citrate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-07-08
Substance
TRISODIUM CITRATE DIHYDRATE
Active strength
230 mg/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nauzene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRISODIUM CITRATE DIHYDRATE230 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB22547B95K
Rxcui2002800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-242-10Nauzene1 in 1 CARTONTABLET, CHEWABLE115
52389-242-10Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-40Nauzene4 in 1 CARTONTABLET, CHEWABLE415
52389-242-40Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-42Nauzene14 in 1 BLISTER PACKTABLET, CHEWABLE1415
52389-242-42Nauzene3 in 1 CARTONTABLET, CHEWABLE315
52389-242-50Nauzene10 in 1 BLISTER PACKTABLET, CHEWABLE1015
52389-242-50Nauzene5 in 1 CARTONTABLET, CHEWABLE515
52389-242-56Nauzene14 in 1 BLISTER PACKTABLET, CHEWABLE1415
52389-242-56Nauzene4 in 1 CARTONTABLET, CHEWABLE415

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRISODIUM CITRATE DIHYDRATEACTIVE INGREDIENTB22547B95KNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
AspartameINACTIVE INGREDIENTZ0H242BBR1NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOANAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WONAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Stearic acidINACTIVE INGREDIENT4ELV7Z65APNAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-242NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]15Current NDC, Legacy NDC, 10 package rows20250430_a60660b2-c5db-45a0-885f-de93e655380d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002800sodium citrate 230 MG Chewable TabletPSNa60660b2-c5db-45a0-885f-de93e655380d15
2002800sodium citrate 230 MG Chewable TabletSCDa60660b2-c5db-45a0-885f-de93e655380d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-242-10523890242101 BLISTER PACK in 1 CARTON (52389-242-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2016-07-150000-00-00NoNoCurrent
52389-242-40523890242404 BLISTER PACK in 1 CARTON (52389-242-40) > 10 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2000-07-080000-00-00NoNoCurrent
52389-242-42523890242423 BLISTER PACK in 1 CARTON (52389-242-42) / 14 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2017-07-060000-00-00NoNoCurrent
52389-242-50523890242505 BLISTER PACK in 1 CARTON (52389-242-50) > 10 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2006-10-010000-00-00NoNoCurrent
52389-242-56523890242564 BLISTER PACK in 1 CARTON (52389-242-56) / 14 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2019-11-160000-00-00NoNoCurrent