BONINE

Product NDC: 65197-296
11-digit product format: 651970296
Labeler code: 65197
Product ID: 65197-296_7c66f984-240b-40dc-affd-9f1562f57c7c
Type: HUMAN OTC DRUG
Nonproprietary name: meclizine hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: WellSpring Pharmaceutical Corporation
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-15
Marketing end: 2026-12-31
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65197-296	65197-296-32	D	Discontinued by firm		2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65197-296	65197-296-32	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65197-296	65197-296-32	D	Discontinued by firm		excluded / ndc_excluded.zip	`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: BONINE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MECLIZINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HDP7W44CIO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995632	Internal RxNorm lookup
995634	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
ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65197-296-08	BONINE	1 in 1 BOX	TABLET, CHEWABLE	1	20
65197-296-08	BONINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	20
65197-296-12	BONINE	12 in 1 BOTTLE	TABLET, CHEWABLE	12	20
65197-296-12	BONINE	1 in 1 BOX	TABLET, CHEWABLE	1	20
65197-296-16	BONINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	20
65197-296-16	BONINE	2 in 1 BOX	TABLET, CHEWABLE	2	20
65197-296-24	BONINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	20
65197-296-24	BONINE	3 in 1 CARTON	TABLET, CHEWABLE	3	20
65197-296-32	BONINE	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	20
65197-296-32	BONINE	4 in 1 CARTON	TABLET, CHEWABLE	4	20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65197-296	BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]	20	Current NDC, Legacy NDC, 10 package rows	20250330_ad3d66ca-a52c-43ba-b9e2-6269b8a413a9.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 5 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HIONFURT Motion Sickness	MOTION SICKNESS NATURAL HERBAL PLANT LAVENDER	Puning Huiyu E-Commerce Co., Ltd.	2e30b09d-838d-59fb-e063-6394a90aa984	2025-02-15	Warnings	Exact identifier application number: M009
HIONFURT Motion Sickness	MOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITING	Puning Huiyu E-Commerce Co., Ltd.	2e31419e-3ccd-d7b5-e063-6394a90ac765	2025-02-15	Warnings	Exact identifier application number: M009
Bedy motion sickness	MOTION SICKNESS RELIEF , NAUSEA RELIEF , SEA SICKNESS	Henan Hengchuntang Pharmaceutical Co., Ltd	2e3bf94c-4e60-7f78-e063-6394a90a7021	2025-02-15	Warnings	Exact identifier application number: M009
Dramamine for Kids	DIMENHYDRINATE	Medtech Products Inc.	3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c	2025-02-12	Warnings	Exact identifier application number: M009
Motion Sickness	MOTION SICKNESS NATURAL HERBAL PLANT	Puning Huiyu E-Commerce Co., Ltd.	2db09ade-c94b-5f5f-e063-6394a90af9dc	2025-02-09	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE 50 MG	TARGET CORPORATION	28586e9b-01e3-0b88-e063-6394a90af7e0	2025-01-29	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5MG	Ulai Health LLC	d304e205-85fa-494a-9a68-ae6855b139b1	2025-01-20	Warnings	Exact identifier application number: M009
Meclizine HCL 12.5 mg	MECLIZINE HCL 12.5 MG	Reliable 1 Laboratories LLC	32832b0f-0b38-27ce-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Reliable 1 Laboratories LLC	32bdd802-16b0-184d-e054-00144ff88e88	2025-01-15	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	e4d785a7-a688-3acb-e053-2a95a90a6d2e	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	APNAR PHARMA LP	ed43bf21-f3da-245c-e053-2995a90a504c	2025-01-09	Boxed warning, Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	RUGBY LABORATORIES	8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35	2024-12-20	Warnings	Exact identifier application number: M009
Meclizine	MECLIZINE HYDROCHLORIDE	Advanced Rx LLC	b0a2a1f7-354e-48bd-9e98-9207bf9f53fd	2024-11-27	Warnings	Exact identifier application number: M009
Dramamine, TRAVEL BASIX	DIMENHYDRINATE	Lil' Drug Store Products, Inc.	960a642b-ee7c-4e92-9b5f-930425682dac	2024-11-26	Warnings	Exact identifier application number: M009
Dramamine Less Drowsy, Lil Drug Store	MECLAZINE HYDROCHLORIDE TABLET	Lil' Drug Store Products, Inc.	275b3377-9280-c12c-e063-6294a90a5421	2024-11-20	Warnings	Exact identifier application number: M009
PhysiciansCare Motion Sickness	MECLIZINE HCL	Acme United Corporation	c4d3ea22-7c22-7311-e053-2a95a90a779c	2024-11-12	Warnings	Exact identifier application number: M009
DRAMAMINE - N	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	7fec7791-c242-4e43-8184-32820e657afb	2024-10-25	Warnings	Exact identifier application number: M009
DRAMAMINE	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	f8cf751a-9f19-4744-a350-cd22303435ee	2024-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d955f612-1265-f1be-e053-2995a90a5345	2024-07-18	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	199ae195-4556-ee88-e063-6394a90a40d4	2024-06-10	Warnings	Exact identifier application number: M009

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995634	Bonine 25 MG Chewable Tablet	PSN	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	20
995632	meclizine HCl 25 MG Chewable Tablet	PSN	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	20
995634	meclizine hydrochloride 25 MG Chewable Tablet [Bonine]	SBD	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	20
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	20
995634	Bonine 25 MG Chewable Tablet	SY	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65197-296-08	65197029608	1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	1 blister pack	2023-02-15	2026-12-31	No	No	Current
65197-296-12	65197029612	1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE	1 bottle	2023-02-15	2026-10-31	No	No	Current
65197-296-16	65197029616	2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	2 blister pack	2023-02-15	2026-12-31	No	No	Current
65197-296-24	65197029624	3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2023-05-01	2026-12-31	No	No	Historical
65197-296-32	65197029632	8 in 1 BLISTER PACK						Historical