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		2026-10-16
excluded package	package	52389-242	52389-242-50	D	Discontinued by firm		2026-10-16

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 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 20 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Ultra Strength Antacid	CALCIUM CARBONATE	CARDINAL HEALTH 110, LLC. DBA LEADER	eab5a905-67fb-494e-8f55-aeeab4c2dce2	2025-08-22	Warnings	Exact identifier application number: M001
Leader Extra Strength Antacid	CALCIUM CARBONATE	CARDINAL HEALTH 110, LLC. DBA LEADER	81911f6d-7edf-4183-9720-2f20a5db498d	2025-08-21	Warnings	Exact identifier application number: M001
Gas Relief	SIMETHICONE	BJWC (Berkley & Jensen / BJ's)	2f32dde8-502e-eefa-e063-6294a90abf20	2025-08-19	Warnings	Exact identifier application number: M001
CVS Health Ultra Strength Natural Antacid Peppermint Flavor	ANTACID TABLETS	CVS Pharmacy,Inc.	4f18fd8d-4d6a-4b1d-8a94-b64592f73ad0	2025-08-13	Warnings	Exact identifier application number: M001
MGC Health Calcium Carbonate Antacid Assorted Berries	CALCIUM CARBONATE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	b84d80c6-0240-4276-8e47-74a918f3d86a	2025-08-12	Warnings	Exact identifier application number: M001
Antacid	CALCIUM CARBONATE	ProStat First Aid	3bb49eb3-2eaa-af8d-e063-6294a90a4035	2025-08-06	Warnings	Exact identifier application number: M001
Maximum Strength Antacid and Antigas	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	Meijer, Inc.	30a0455d-63e0-95cc-e063-6394a90ada6b	2025-07-30	Warnings	Exact identifier application number: M001
Sodium Bicarbonate Antacid	SODIUM BICARBONATE	Menper Distributors Inc.	6efb4da0-03ae-4df6-acd7-e8023d20d4b3	2025-07-22	Warnings	Exact identifier application number: M001
Gas-X Total Relief Maximum Strength	CALCIUM CARBONATE, SIMETHICONE	Haleon US Holdings LLC	edb0f11a-bdb7-484d-9257-09ff47b0fca4	2025-07-15	Warnings	Exact identifier application number: M001
REGULAR STRENGTH ANTACID ANTIGAS	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE	WALGREEN COMPANY	7cd9234e-d1cc-4cce-e053-2991aa0a457e	2025-07-09	Warnings	Exact identifier application number: M001
Sodium Bicarbonate	SODIUM BICARBONATE	Westminster Pharmaceuticals, LLC	9dcfc778-5fd6-4c68-8d37-a5385e374617	2025-07-08	Warnings	Exact identifier application number: M001
MGC Health Antacid Soft Chews Cherry Flavor	CALCIUM CARBONATE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3958ec0a-8f32-6918-e063-6294a90ac1c4	2025-07-07	Warnings	Exact identifier application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	Major Pharmaceuticals	1bc90fa7-fcce-4a9b-862f-f30ab602ecab	2025-07-07	Warnings	Exact identifier application number: M001
KOSHER MEDS antacid	CALCIUM CARBONATE	Mollec Inc	7783d6a2-56e3-4542-ad1d-60680e03532b	2025-07-01	Warnings	Exact identifier application number: M001
Nauzene Chewables Ginger Honey	SODIUM CITRATE	Kobayashi Healthcare International, Inc.	25c9825d-a4e8-4671-e063-6294a90ab46d	2025-06-24	Warnings	Exact identifier application number: M001
Gaviscon Extra Strength	ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE	Haleon US Holdings LLC	7f367927-c366-465c-a059-e2cfb337d562	2025-06-11	Warnings	Exact identifier application number: M001
Calmicid AC Acid Reducer	FAMOTIDINE	Melaleuca, Inc.	369ae213-cd23-57ba-e063-6394a90a87a6	2025-06-02	Warnings	Exact identifier application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone	ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE	American Health Packaging	2faf291e-1d62-412a-a05e-e992cb7def6a	2025-05-30	Warnings	Exact identifier application number: M001
Kids Tummy Relief	CALCIUM CARBONATE	Genexa Inc.	a7831b84-1f51-9258-e053-2a95a90a901e	2025-05-23	Warnings	Exact identifier application number: M001
Calcium Carbonate	CALCIUM CARBONATE	Atlantic Biologicals Corps	38654d22-2f8a-49d2-a1cd-06d341f11323	2025-05-12	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