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Pseudoephedrine HCl

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Pseudoephedrine HCl
Generic name
Pseudoephedrine HCl
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Better Living Brands LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
3
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Pseudoephedrine Hydrochloride 120 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha-Agonists [MoA] MoA All 85 members
alpha-Adrenergic Agonist [EPC] EPC All 85 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209008
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 9, 2017
Sponsor
AUROBINDO PHARMA
Products on application
1
Submissions recorded
1
Products approved under application 209008.
Product Trade name Form Strength Ingredient Status TE Flags
209008-001 PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209008.
Type No. Action Status Date Review
Original application 1 Approved June 9, 2017 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240724). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240724

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Purpose

openFDA Drug Labeling

Purpose Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

Do Not Use

openFDA Drug Labeling

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.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Pseudoephedrine HCl USP 120 mg

Adverse event reports

Source: openFDA FAERS
36,595
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PSEUDOEPHEDRINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
58602-804-67 58602-804 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-804-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 9, 2017
58602-804-83 58602-804 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-804-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 9, 2017
21130-158-67 21130-158 Better Living Brands LLC 2 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK September 1, 2023
58602-804 58602-804 Aurohealth LLC — June 9, 2017
21130-158 21130-158 Better Living Brands LLC — September 1, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.