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 firm2026-10-16
excluded packagepackage52389-24252389-242-50DDiscontinued by firm2026-10-16

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 30 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodsense Extra Strength AntacidCALCIUM CARBONATEGoodSense193a1805-9f57-29cd-e063-6394a90ab99f2024-09-13WarningsExact identifier
application number: M001
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
application number: M001
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
application number: M001
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
application number: M001
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC72ac000c-90f7-42e2-88a6-740de114a9542024-08-21WarningsExact identifier
application number: M001
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
application number: M001
Wonderbelly Maximum Strength Antacid - Sweet MintCALCIUM CARBONATEGinger Health Company17ddf76b-237a-eeee-e063-6294a90ac2052024-07-29WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Regular StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation2847e82e-203e-4976-8c4f-4a5caa75ce002024-07-09WarningsExact identifier
application number: M001
Kirkland Ultra Stregth Antacid 171ABCALCIUM CARBONATECOSTCO WHOLESALE COMPANY1bea92e8-1b94-77b0-e063-6394a90a82122024-07-08WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa951fa64-7775-470e-e053-2995a90aefc42024-06-10WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals,Inc.5b1f4c78-d42e-32c7-e053-2991aa0a19852024-06-04WarningsExact identifier
application number: M001
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
application number: M001
Stomach Circle KBISMUTH SUBSALICYLATELil' Drug Store Products, Inc05e14009-b35d-4711-b6f0-89b6d060b3872024-05-06WarningsExact identifier
application number: M001
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
application number: M001
MINT ANTACID 100CALCIUM CARBONATEJHK Inc dba American Safety & First Aid2496aed6-68ec-44c4-afc9-f7fa41b2147b2024-04-24WarningsExact identifier
application number: M001
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
application number: M001
Gas-X Maximum Strength SoftgelsSIMETHICONEHaleon US Holdings LLC45d1e373-0717-47df-9160-619c451666f42024-04-05WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact 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