MECLIZINE HYDROCHLORIDE

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: MECLIZINE HYDROCHLORIDE
Generic name: MECLIZINE HYDROCLORIDE
Manufacturer: NuCare Pharmaceuticals,Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 64a508ae-768a-2fba-e053-2991aa0ac42d
SPL ID: 1d788e6f-633a-a344-e063-6294a90a90d1
Version: 5
Effective date: 2024-07-17
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:20:51

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	040659	derived:openfda.application_number
application number		ANDA040659	openfda.application_number
brand name		MECLIZINE HYDROCHLORIDE	openfda.brand_name
generic name		MECLIZINE HYDROCLORIDE	openfda.generic_name
manufacturer name		NuCare Pharmaceuticals,Inc.	openfda.manufacturer_name
ndc	package	68071-3017-7	openfda.package_ndc
ndc	package	68071-3017-1	openfda.package_ndc
ndc	package	68071-3017-6	openfda.package_ndc
ndc	package	68071-3017-2	openfda.package_ndc
ndc	package	68071-3017-3	openfda.package_ndc
ndc	package	68071-3017-9	openfda.package_ndc
ndc	product	68071-3017	openfda.product_ndc
ndc11	package	68071301703	derived:openfda.package_ndc
ndc11	package	68071301702	derived:openfda.package_ndc
ndc11	package	68071301701	derived:openfda.package_ndc
ndc11	package	68071301707	derived:openfda.package_ndc
ndc11	package	68071301706	derived:openfda.package_ndc
ndc11	package	68071301709	derived:openfda.package_ndc
rxcui		995666	openfda.rxcui
spl id		1d788e6f-633a-a344-e063-6294a90a90d1	id
spl set id		64a508ae-768a-2fba-e053-2991aa0ac42d	set_id
unii		HDP7W44CIO	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.