Meclizine HCl

Product NDC: 68001-529
11-digit product format: 680010529
Labeler code: 68001
Product ID: 68001-529_11d28658-55a1-ff25-e063-6394a90a7e65
Type: HUMAN OTC DRUG
Nonproprietary name: MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: BluePoint Laboratories
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-03-14
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Meclizine HCl
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995632	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
d9cc2705-9dcc-0a73-e053-2995a90aafe6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-529-00	Meclizine HCl	100 in 1 BOTTLE	TABLET, CHEWABLE	100		2
68001-529-08	Meclizine HCl	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-529-00	EA - Each	68001-529	0e17c453-0e76-44a8-be97-86850ebbce92	1	2022-04-06
68001-529-08	EA - Each	68001-529	392cc8fc-6d12-4f6d-9668-d9477ef4a449	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-529	MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [BLUEPOINT LABORATORIES]	2	Current NDC, Legacy NDC, 2 package rows	20240222_d9cc2705-9dcc-0a73-e053-2995a90aafe6.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Airmit Ace	DIMENHYDRINATE	Sato Pharmaceutical Co., Ltd.	a98d252d-4cfa-496a-ab2c-627f45f0d7d9	2023-12-01	Warnings	Exact identifier application number: M009
Meclizine HCl	MECLIZINE HYDROCHLORIDE	BluePoint Laboratories	d9cae5a6-8d4b-bdaf-e053-2995a90a7d44	2023-11-17	Warnings	Exact identifier application number: M009
ZenTrip Motion Sickness	MECLIZINE HYDROCHLORIDE	Sato Pharmaceutical Co., LTD	bd86c4c7-b6f0-e3e8-e053-2995a90a4454	2023-11-03	Warnings	Exact identifier application number: M009
Travel-Ease	MECLIZINE HCL	Geri-Care Pharmaceutical Corp	e3c64eb9-4972-29d9-e053-2a95a90a2a8a	2023-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d95240bb-02f2-3226-e053-2995a90afacd	2022-03-03	Warnings	Exact identifier application number: M009
Allergy DyeFree	ALLERGY DYEFREE	Allegiant Health	15736bb8-5a5b-489d-83ad-4cf34ec62956	2021-04-26	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE 50MG	Allegiant Health	7b0aa993-f08f-4dff-a82d-f35b3ebe3cc1	2019-12-12	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
995632	meclizine HCl 25 MG Chewable Tablet	PSN	d9cc2705-9dcc-0a73-e053-2995a90aafe6	2
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	d9cc2705-9dcc-0a73-e053-2995a90aafe6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-529-00	68001052900	100 TABLET, CHEWABLE in 1 BOTTLE (68001-529-00)	2022-03-14	0000-00-00	No	No	Current
68001-529-08	68001052908	1000 TABLET, CHEWABLE in 1 BOTTLE (68001-529-08)	2022-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS, 25 MG	BluePoint Laboratories \| Unique Pharmaceutical Laboratories	2024-02-21	HUMAN OTC DRUG LABEL	2