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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dramamine Orange	DIMENHYDRINATE	Medtech Products Inc.	76166156-bce1-492f-833e-6bbd07859c3f	2026-09-17	Warnings	Exact identifier application number: M009
Pepto Nausea Motion Sickness	MECLIZINE HCL	THE PROCTER & GAMBLE MANUFACTURING COMPANY	29a1bd1e-d0e0-478f-e063-6394a90ab0aa	2026-09-10	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	A-S Medication Solutions	2518b0b6-35ab-49f4-936c-1eafea04b466	2026-09-09	Warnings	Exact identifier application number: M009
Dramamine Less Drowsy	MECLIZINE HYDROCHLORIDE	Medtech Products Inc.	fa6a0969-7427-4b87-bc04-a2792665c218	2026-09-04	Warnings	Exact identifier application number: M009
Less Drowsy Motion Sickness Relief	MECLIZINE HCL	Wal-Mart Stores Inc	277a6266-e641-4621-bbb9-64195d51b66a	2026-08-28	Warnings	Exact identifier application number: M009
Nausea Relief	MECLIZINE HCL	WALMART INC.	8010741e-61b2-4c1f-9f0e-21612878fa0e	2026-08-28	Warnings	Exact identifier application number: M009
Motion Sickness	MECLIZINE HCL	H E B	9837e9af-c542-4c0f-be33-94927d67c6a7	2026-08-21	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	cd82fca9-a8dc-4545-8e64-b67d644832e7	2026-08-20	Warnings	Exact identifier application number: M009
Motion Sickness	DIMENHYDRINATE	Strategic Sourcing Services LLC	be8f91d4-6e4f-4d47-93e9-7fb91160b7df	2026-08-17	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Walgreen Company	ace7eba4-e033-48f5-8533-c3ea9dfc32b0	2026-08-12	Warnings	Exact identifier application number: M009
Motion Sickness	MECLIZINE HCL	Strategic Sourcing Services LLC	76fb6471-09b0-4c51-bacc-b3533b6aa971	2026-08-07	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Cardinal Health 110, LLC. DBA Leader	ce83a868-bdd8-4c77-9bc0-664133028f75	2026-08-06	Warnings	Exact identifier application number: M009
Less Drowsy Formula Motion Sickness Relief	MECLIZINE HCL	Salado Sales, Inc.	273235b0-dacc-4a95-91be-91e13a2c6d10	2026-08-05	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	L.N.K. International, Inc.	8e1889de-fbef-44f1-bbfb-c68a78e6330c	2026-07-30	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	Chain Drug Marketing Association, Inc.	00a327c6-6b86-4702-8c04-55c405c1404c	2026-07-23	Warnings	Exact identifier application number: M009
Pepto Motion Sickness	MECLIZINE HCL	THE PROCTER & GAMBLE MANUFACTURING COMPANY	571e3eeb-ae9e-7054-e063-6394a90a2634	2026-07-21	Warnings	Exact identifier application number: M009
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rugby Laboratories	b57f14a7-3852-03db-e053-2a95a90a80d6	2026-07-16	Warnings	Exact identifier application number: M009
Motion Sickness	DIMENHYDRINATE	CVS Pharmacy	0998947c-cfba-497e-bf7a-9c7f8fff1764	2026-07-16	Warnings	Exact identifier application number: M009
Motion Sickness Relief	MECLIZINE HCL	Topco Associates, LLC	307e3144-3b01-4bd0-9155-6b58fc4cab92	2026-07-09	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE	L.N.K. International, Inc.	95aae32f-6b3f-469d-86a5-c201a53f862a	2026-06-29	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