NeoTuss Plus FDA Label

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: NeoTuss Plus
Generic name: DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
Manufacturer: DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 2fabd782-14dc-1d1b-e063-6394a90af428
SPL ID: 463c45eb-d68e-f00f-e063-6394a90acc91
Version: 2
Effective date: 2025-12-18
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:11:02

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		NeoTuss Plus	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	openfda.manufacturer_name
ndc	package	12539-779-16	openfda.package_ndc
ndc	product	12539-779	openfda.product_ndc
ndc11	package	12539077916	derived:openfda.package_ndc
rxcui		2167750	openfda.rxcui
spl id		463c45eb-d68e-f00f-e063-6394a90acc91	id
spl set id		2fabd782-14dc-1d1b-e063-6394a90af428	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		V1Q0O9OJ9Z	openfda.unii

Canonical DailyMed SPL 2fabd782-14dc-1d1b-e063-6394a90af428

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.

warnings and cautions

Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect.

Reported adverse events (FAERS/openFDA)#

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

NeoTuss Plus