Goodmeds Levocetirizine Dihydrochloride 5mg 365 count

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: Goodmeds Levocetirizine Dihydrochloride 5mg 365 count
Generic name: LEVOCETIRIZINE DIHYDROCHLORIDE 5MG
Manufacturer: Cabinet Health P.B.C.
Product type: HUMAN OTC DRUG
SPL set ID: 54f34304-952e-2f07-e063-6394a90a80ee
SPL ID: 54f34304-952f-2f07-e063-6394a90a80ee
Version: 1
Effective date: 2026-06-23
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:17:57

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	213513	derived:openfda.application_number
application number		ANDA213513	openfda.application_number
brand name		Goodmeds Levocetirizine Dihydrochloride 5mg 365 count	openfda.brand_name
generic name		LEVOCETIRIZINE DIHYDROCHLORIDE 5MG	openfda.generic_name
manufacturer name		Cabinet Health P.B.C.	openfda.manufacturer_name
ndc	package	82725-4051-1	openfda.package_ndc
ndc	product	82725-4051	openfda.product_ndc
ndc11	package	82725405101	derived:openfda.package_ndc
rxcui		855172	openfda.rxcui
spl id		54f34304-952f-2f07-e063-6394a90a80ee	id
spl set id		54f34304-952e-2f07-e063-6394a90a80ee	set_id
unii		SOD6A38AGA	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 Do not use If you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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