DEXTROMETHORPHAN POLISTIREX

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: DEXTROMETHORPHAN POLISTIREX
Generic name: DEXTROMETHORPHAN POLISTIREX
Manufacturer: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 759acdcd-d8d0-41d0-8b80-7f81fe196a9f
SPL ID: e568400c-98ea-4f20-be34-1fb3e05bb72b
Version: 3
Effective date: 2026-05-04
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:08:31

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	218417	derived:openfda.application_number
application number		ANDA218417	openfda.application_number
brand name		DEXTROMETHORPHAN POLISTIREX	openfda.brand_name
generic name		DEXTROMETHORPHAN POLISTIREX	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-611-05	openfda.package_ndc
ndc	package	58602-611-06	openfda.package_ndc
ndc	product	58602-611	openfda.product_ndc
ndc11	package	58602061105	derived:openfda.package_ndc
ndc11	package	58602061106	derived:openfda.package_ndc
rxcui		1373045	openfda.rxcui
spl id		e568400c-98ea-4f20-be34-1fb3e05bb72b	id
spl set id		759acdcd-d8d0-41d0-8b80-7f81fe196a9f	set_id
unii		7355X3ROTS	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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Reported adverse events (FAERS/openFDA)#

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