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 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	CVS Pharmacy, Inc	b57fc6c2-fbfc-24c3-e053-2995a90a3389	2025-10-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Amerisource Bergen	503f62e7-8ec8-4409-9697-4efef4ff7b15	2025-10-08	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Proficient Rx LP	d08fa6f5-4293-4468-814e-7dccbd281209	2025-10-01	Warnings	Exact identifier application number: M009
Dramamine for Kids	DIMENHYDRINATE	Medtech Products Inc.	12bc3f17-ed62-4d0d-9b1e-3835579e711b	2025-09-10	Warnings	Exact identifier application number: M009
Medique Medi-Meclizine	MECLIZINE HCL	Unifirst First Aid Corporation	b3fec2df-c41d-0b56-e053-2995a90a35e8	2025-09-09	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HYDROCHLORIDE	TARGET CORPORATION	36ba2950-4a09-e5de-e063-6394a90a1771	2025-09-04	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 12.5 MG	Advanced Rx LLC	032a89f2-17e7-45d2-94a1-cc7a601ebdee	2025-09-01	Warnings	Exact identifier application number: M009
Dimenhydrinate	DIMENHYDRINATE	Major Pharmaceuticals	78d22836-a442-7c0c-e053-2991aa0a62f3	2025-08-13	Warnings	Exact identifier application number: M009
MQ Motion Patch	MOTION PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	3a70bc22-8e31-2d4c-e063-6394a90a3b24	2025-07-21	Warnings	Exact identifier application number: M009
Bangbrek Bee Venom Wart Corn Callus Remover	SALICYLIC ACID 17%	Brilliance Trade LLC	377946a0-0e8c-70f4-e063-6294a90a1d85	2025-06-20	Warnings	Exact identifier application number: M009
Dramamine for Kids	DIMENHYDRINATE	Medtech Products Inc.	48e2e9ef-4c88-42ef-b825-d1b007475275	2025-05-06	Warnings	Exact identifier application number: M009
BONINE MAX	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	7326a47e-284e-4b6f-8eb0-7933dc1e3f0d	2025-04-11	Warnings	Exact identifier application number: M009
Meclizine HCL 25 mg	MECLIZINE HCL	Bryant Ranch Prepack	d1c58a74-5455-4a07-bcb6-cc114032ed12	2025-03-31	Warnings	Exact identifier application number: M009
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	2025-03-21	Warnings	Exact identifier application number: M009 ndc (product): 65197-296
BONINE	MECLIZINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	0b2ea6b8-b342-4940-8922-898758fbeb31	2025-03-21	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Walgreen Company	ecf8d05e-0e77-f3e8-e053-2a95a90a6604	2025-03-11	Warnings	Exact identifier application number: M009
MECLIZINE	MECLIZINE HCL 25MG	PD-Rx Pharmaceuticals, Inc.	cf79ac74-017e-4fb4-85d3-4ea944080e89	2025-03-06	Warnings	Exact identifier application number: M009
Bedy Motion Sickness Patches	MOTION SICKNESS RELIEF PATCHES, NAUSEA RELIEF PATCHES, SEA SICKNESS PATCHES	Henan Hengchuntang Pharmaceutical Co., Ltd	2e57d2b7-875e-4e20-e063-6394a90acab6	2025-02-17	Warnings	Exact identifier application number: M009
HIONFURT Motion Sickness	MOTION SICKNESS NATURAL HERBAL PLANT	Puning Huiyu E-Commerce Co., Ltd.	2e2c9073-1dcf-a3e8-e063-6394a90a6ee3	2025-02-15	Warnings	Exact identifier application number: M009
HIONFURT Motion Sickness	MOTION SICKNESS NATURAL HERBAL PLANT LEMON	Puning Huiyu E-Commerce Co., Ltd.	2e2b3729-f8b0-605f-e063-6294a90a90c8	2025-02-15	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