Triamcinolone Acetonide Nasal — Spray, Metered

Overview

Brand name

Triamcinolone Acetonide Nasal

Generic name

Triamcinolone acetonide

Dosage form

Spray, Metered

Route

Nasal

Marketing category

ANDA · ANDA

Labeler

Padagis Israel Pharmaceuticals Ltd

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

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
Triamcinolone Acetonide	55 ug/1	1014314	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Spray, Metered

Route of administration

Nasal

Presentations

4

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
Corticosteroid Hormone Receptor Agonists [MoA]	MoA	All 215 members
Corticosteroid [EPC]	EPC	All 215 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

078104

Application type

ANDA · Abbreviated New Drug Application

Approval date

July 30, 2009

Sponsor

PERRIGO PHARMA INTL

Products on application

2

Submissions recorded

6

Products approved under application 078104.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
078104-001	TRIAMCINOLONE ACETONIDE	SPRAY, METERED		TRIAMCINOLONE ACETONIDE	Discontinued	—
078104-002	TRIAMCINOLONE ACETONIDE	SPRAY, METERED		TRIAMCINOLONE ACETONIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 078104.
Type	No.	Action	Status	Date	Review
Supplement	17	Labeling	Approved	November 12, 2020	Standard
Supplement	11	Labeling	Approved	November 12, 2020	Standard
Supplement	6	Labeling	Approved	November 12, 2020	Standard
Supplement	7	Manufacturing (CMC)	Approved	May 25, 2018	—
Supplement	3	Labeling	Approved	November 14, 2014	Standard
Original application	1		Approved	July 30, 2009	—

Review documents

0 · Original application · August 6, 2009
0 · Original application · July 30, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240814). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240814 HUMAN OTC DRUG · 20240725

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose

Purpose

openFDA Drug Labeling

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions Read insert (inside package) on how to: • get a new bottle ready (primed) before first use • prime bottle again if not used for more than 2 weeks • use the spray • clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older • once daily, spray 2 times into each nostril while sniffing gently • once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 2 TO UNDER 12 YEARS OF AGE • the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. children 6 to under 12 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently • if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day. children 2 to under 6 years of age • an adult should supervise use • once daily, spray 1 time into each nostril while sniffing gently children under 2 years of age • do not use • do not use more than directed • if you forget a dose, do not double the next dose • do not spray into eyes or mouth • if allergy symptoms do not improve after one week, stop using and talk to a doctor • do not use for the common cold • shake well before each use

Warnings

openFDA Drug Labeling

Warnings Do not use • in children under 2 years of age • if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you • have had recent nose ulcers or nose surgery • have had a nose injury that has not healed • are using a steroid medicine for asthma, allergies or skin rash • have an eye infection • have or had glaucoma or cataracts When using this product • the growth rate of some children may be slower • some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief. • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chickenpox, measles or tuberculosis • you have or develop symptoms of an infection such as a persistent fever • you have any change in vision • you have severe or frequent nosebleeds If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use • in children under 2 years of age • if you have ever had an allergic reaction to any of the ingredients

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you • have had recent nose ulcers or nose surgery • have had a nose injury that has not healed • are using a steroid medicine for asthma, allergies or skin rash • have an eye infection • have or had glaucoma or cataracts

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • you have, or come into contact with someone who has, chickenpox, measles or tuberculosis • you have or develop symptoms of an infection such as a persistent fever • you have any change in vision • you have severe or frequent nosebleeds

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Triamcinolone acetonide 55 mcg (glucocorticoid)

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Triamcinolone Acetonide Nasal Spray 55 mcg per spray NDC 72162-2289-2: 120 Nasal Sprays in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Adverse event reports

Source: openFDA FAERS

31,697

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: TRIAMCINOLONE ACETONIDE. 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
72162-2289-2	72162-2289	Bryant Ranch Prepack	1 BOTTLE in 1 CARTON (72162-2289-2) / 120 SPRAY, METERED in 1 BOTTLE	March 28, 2017
45802-109-01	45802-109	Padagis Israel Pharmaceuticals Ltd	1 BOTTLE in 1 CARTON (45802-109-01) / 120 SPRAY, METERED in 1 BOTTLE	March 28, 2017
72162-2289	72162-2289	Bryant Ranch Prepack	—	March 28, 2017
45802-109	45802-109	Padagis Israel Pharmaceuticals Ltd	—	March 28, 2017

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.