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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52389-242	52389-242-40	D	Discontinued by firm		2026-09-14
excluded package	package	52389-242	52389-242-50	D	Discontinued by firm		2026-09-14

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	52389-242-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-242-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-242-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-242-40	`f5e01cc5f278…`	`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
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a60660b2-c5db-45a0-885f-de93e655380d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 1 of 38 · 747 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Stomach Relief	CALCIUM CARBONATE	Wal-Mart Stores Inc	7471ec99-6c0b-40d8-a9cf-85240a0d471a	2026-09-09	Warnings	Exact identifier application number: M001
Walgreens Orange Antacid Soft Chew	CALCIUM CARBONATE	Walgreens	5b01be31-5871-d4f5-e063-6294a90a671a	2026-09-08	Warnings	Exact identifier application number: M001
Regular Strength Tropical Fruit	CALCIUM CARBONATE	RARITAN PHARMACEUTICALS INC	38c6cece-71a0-40d8-bfc8-2f6467f9239b	2026-09-05	Warnings	Exact identifier application number: M001
Extra Strength Antacid Assorted Berries	CALCIUM CARBONATE	RARITAN PHARMACEUTICALS INC	07a50168-6b05-4c99-9969-7d7f0aa54f30	2026-09-05	Warnings	Exact identifier application number: M001
DRx CHOICE Antacid Calcium Regular Strength	CALCIUM CARBONATE 500MG	Raritan Pharmaceuticals Inc	0c579405-9397-4bf2-8441-e89011b19ec4	2026-09-05	Warnings	Exact identifier application number: M001
Tums Chewy Bites Wintermint and Vanilla Cream	CALCIUM CARBONATE	Haleon US Holdings LLC	4f094feb-8de1-4ccb-e063-6294a90acec2	2026-09-04	Warnings	Exact identifier application number: M001
DG health Ultra Strength Assorted Fruit Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	98a0503c-add5-4453-9d9d-6f813866f4b3	2026-09-03	Warnings	Exact identifier application number: M001
DG health Ultra Strength Assorted Berry Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	99c7ab95-df12-4041-ae1a-398cc6f0085d	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Ultra Strength	ANTACID TABLETS (CALCIUM CARBONATE)	DOLGENCORP, LLC	e7be2ad1-c85c-4ac7-b6e7-641f979d0d6b	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Liquid Antacid plus Anti Gas	CALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONE	DOLGENCORP, LLC	8ecb4418-e647-49b5-b418-1c63bb3e5a3c	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	4942747a-8b6c-422a-8150-9bd91c0a3778	2026-09-03	Warnings	Exact identifier application number: M001
DG HEALTH Regular Strength	ANTACID TABLETS (CALCIUM CARBONATE)	DOLGENCORP, LLC	13dd2758-a372-4b0e-bc99-56a2dacbf95f	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid Wintergreen flavor	CALCIUM CARBONATE	DOLGENCORP, LLC	b84b3509-3178-4616-9bec-dad85a4f9d2a	2026-09-03	Warnings	Exact identifier application number: M001
DG Health Regular Strength Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	59ad3cc7-4144-442f-a37d-75c5fe23e1ae	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Assorted Fruits Antacid	CALCIUM CARBONATE	DOLGENCORP, LLC	112f1002-c007-4363-ade6-8dfbc61f4b64	2026-09-03	Warnings	Exact identifier application number: M001
DG health Extra Strength Antacid	SMOOTH DISSOLVE CALCIUM CARBONATE	DOLGENCORP, LLC	cabaa8f7-9c93-439d-905a-5ef643a08ea8	2026-09-03	Warnings	Exact identifier application number: M001
Kroger Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	THE KROGER CO.,	175d9f0f-266a-4dc2-865f-d1ebd4ddac51	2026-09-01	Warnings	Exact identifier application number: M001
Kids Antacid	CALCIUM CARBONATE	THE KROGER CO.	d77c629b-5308-4b71-9024-9899cf88dbae	2026-09-01	Warnings	Exact identifier application number: M001
Kroger Extra Strength Smooth Antacid Assorted Berry	CALCIUM CARBONATE	KROGER COMPANY	4c8d39d9-9d58-45df-9ffd-2cdc41539c03	2026-09-01	Warnings	Exact identifier application number: M001
Kroger Ultra Strength Assorted Fruit	CALCIUM CARBONATE	KROGER COMPANY	b60ced06-725c-4dae-abbf-21cab9e431f9	2026-08-31	Warnings	Exact identifier application number: M001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B22547B95K	TRISODIUM CITRATE DIHYDRATE	6132-04-3	TRISODIUM CITRATE DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2002800	sodium citrate 230 MG Chewable Tablet	PSN	a60660b2-c5db-45a0-885f-de93e655380d	15
2002800	sodium citrate 230 MG Chewable Tablet	SCD	a60660b2-c5db-45a0-885f-de93e655380d	15

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nauzene Chewables	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2025-04-29	HUMAN OTC DRUG LABEL	15