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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52389-24252389-242-40DDiscontinued by firm2026-10-20
excluded packagepackage52389-24252389-242-50DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0552389-242-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0552389-242-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2652389-242-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2652389-242-40f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B22547B95KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2002800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a60660b2-c5db-45a0-885f-de93e655380dAvailable on FDA.report

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

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 34 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY,INC.53fc327e-e345-26f2-e054-00144ff8d46c2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
application number: M001
CALCIUM CARBONATE CHEWABLE ANTACIDCALCIUM CARBONATEGeri-Care Pharmaceutical Corp27d9b505-08bd-4261-a59d-6ddc4031be322023-10-25WarningsExact identifier
application number: M001
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd5c123f8-1396-4d8c-96d3-e5ade96a6ef82020-11-10WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
application number: M001
Magnesium Oxide 400mgMAGNESIUM OXIDE 400MGAllegiant Health2ea68874-8c20-4284-bd0a-f07768057b832019-01-28WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health51dd53e8-22ff-4967-9124-f15c3986e4dd2017-11-17WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health551d6135-2650-4c27-a20d-d56a9aba7b712017-11-08WarningsExact identifier
application number: M001

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