Home NDC 52389-242 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 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.
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 Ingredient Strength TRISODIUM CITRATE DIHYDRATE 230 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B22547B95K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2002800 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52389-242-10 Nauzene 1 in 1 CARTON TABLET, CHEWABLE 1 15 52389-242-10 Nauzene 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 15 52389-242-40 Nauzene 4 in 1 CARTON TABLET, CHEWABLE 4 15 52389-242-40 Nauzene 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 15 52389-242-42 Nauzene 14 in 1 BLISTER PACK TABLET, CHEWABLE 14 15 52389-242-42 Nauzene 3 in 1 CARTON TABLET, CHEWABLE 3 15 52389-242-50 Nauzene 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 15 52389-242-50 Nauzene 5 in 1 CARTON TABLET, CHEWABLE 5 15 52389-242-56 Nauzene 14 in 1 BLISTER PACK TABLET, CHEWABLE 14 15 52389-242-56 Nauzene 4 in 1 CARTON TABLET, CHEWABLE 4 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRISODIUM CITRATE DIHYDRATE ACTIVE INGREDIENT B22547B95K NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 ANHYDROUS CITRIC ACID ACTIVE MOIETY XF417D3PSL NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Aspartame INACTIVE INGREDIENT Z0H242BBR1 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Magnesium stearate INACTIVE INGREDIENT 70097M6I30 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Maltodextrin INACTIVE INGREDIENT 7CVR7L4A2D NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) INACTIVE INGREDIENT 461P5CJN6T NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Stearic acid INACTIVE INGREDIENT 4ELV7Z65AP NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-242 NAUZENE (SODIUM CITRATE) TABLET, CHEWABLE [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 15 Current NDC, Legacy NDC, 10 package rows 20250430_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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52389-242-10 52389024210 1 BLISTER PACK in 1 CARTON (52389-242-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 1 blister pack 2016-07-15 0000-00-00 No No Current 52389-242-40 52389024240 4 BLISTER PACK in 1 CARTON (52389-242-40) > 10 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2000-07-08 0000-00-00 No No Current 52389-242-42 52389024242 3 BLISTER PACK in 1 CARTON (52389-242-42) / 14 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2017-07-06 0000-00-00 No No Current 52389-242-50 52389024250 5 BLISTER PACK in 1 CARTON (52389-242-50) > 10 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2006-10-01 0000-00-00 No No Current 52389-242-56 52389024256 4 BLISTER PACK in 1 CARTON (52389-242-56) / 14 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2019-11-16 0000-00-00 No No Current