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 firm2026-10-15
excluded packagepackage52389-24252389-242-50DDiscontinued by firm2026-10-15

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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids Ultra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.8806c912-ab83-4f45-ac78-e826bb3143d42026-01-14WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Wild BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.07649a83-0123-4bb5-b130-3067c7d052c52026-01-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e1a46c-5665-ac4c-e063-6294a90a9b812026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e19b30-3784-ad98-e063-6294a90aa5662026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEMedical Group Care LLC47e1bc32-baf5-ad9a-e063-6294a90ad5b42026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC47e1c7c7-4f3b-c04b-e063-6394a90a775f2026-01-08WarningsExact identifier
application number: M001
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
application number: M001
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
application number: M001
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
application number: M001
QC Ultra Strength Antacid Soft Chews, CherryQC ANTACID SOFT CHEWS, CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a97517-d3e7-d896-e063-6394a90acc952025-12-29WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATESelect Consumer Group3caa037e-3424-f9ce-e063-6294a90ac1e82025-12-27WarningsExact identifier
application number: M001
AntacidANTACIDXiamen Kang Zhongyuan Biotechnology Co., Ltd.17adb983-bb28-bf8b-e063-6394a90a7daa2025-12-26WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact 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