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Triamcinolone acetonide

Over-the-counter Veterinary 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
Triamcinolone acetonide
Generic name
Triamcinolone acetonide
Dosage form
Spray, Metered
Route
Nasal
Marketing category
ANDA · ANDA
Labeler
Bespak HC Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
8
Packages
14
Data completeness
82% 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 mg/g 1014314 View
Triamcinolone Acetonide 55 ug/1 1014314 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
22

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@FDANDC Directory
Application number
214615
Application type
ANDA · Abbreviated New Drug Application
Approval date
January 19, 2023
Sponsor
APOTEX
Products on application
1
Submissions recorded
1
Products approved under application 214615.
Product Trade name Form Strength Ingredient Status TE Flags
214615-001 TRIAMCINOLONE ACETONIDE SPRAY, METERED TRIAMCINOLONE ACETONIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 214615.
Type No. Action Status Date Review
Original application 1 Approved January 19, 2023 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260813). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260813 HUMAN OTC DRUG · 20260521 HUMAN OTC DRUG · 20250729

Indications and Usage

openFDA Drug Labeling

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Triamcinolone Acetonide Nasal Spray, USP 55 mcg per spray IMPORTANT INFORMATION Read both sides of this insert for complete instructions on how to get a bottle ready (primed), how to use the spray bottle and how to clean the spray nozzle. Keep this insert as it contains important information. STEPS TO GET A NEW BOTTLE READY FOR USE (PRIMED) 1. Before first use, a new bottle must be primed. a. Remove cap and safety clip (Figure A). b. Shake bottle. c. Press and release spray nozzle until a fine mist is produced (as shown in Figure B). This may take several times. Take care not to spray in face. PRIME BOTTLE AGAIN IF NOT USED FOR MORE THAN 2 WEEKS Repeat steps for priming a bottle (see above). USE INSTRUCTIONS 1. Blow nose gently to clear nostrils. 2. Remove cap and safety clip, then shake bottle. 3. Hold bottle with thumb under bottle and spray nozzle between fingers (as shown in Figure B). 4. Press against the outside of your nose with your finger to close off one nostril (as shown in Figure C) . 5. Place the tip of the spray nozzle into the other nostril. The spray nozzle should not reach far into the nose. Aim nozzle toward back of nose (as shown in Figure C) . DO NOT spray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D) . 6. While sniffing gently, spray into nostril. IMPORTANT: For complete dosing instructions, See “Directions for use” on next side. 7. Repeat steps “4” through “6” for the other nostril. 8. After using the nasal spray, wipe nozzle with a tissue, replace safety clip, and replace cap by pressing it down over the spray nozzle. NOTE: Avoid blowing nose for 15 minutes after use. If nozzle does not spray properly, see cleaning instructions on next side. (continued on side 2) SIDE 1 DIRECTIONS FOR USE BEFORE first use, you must get a new bottle ready (primed). If bottle is not used for more than 2 weeks, prime bottle again. Dosing 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 Other important information for 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 you get the spray in your eyes, rinse well with water. If allergy symptoms do not improve after one week, stop using and talk to a doctor. Do not share this bottle with anyone else as this may spread germs. IF PUMP DOES NOT SPRAY PROPERLY, THE NOZZLE MAY BE BLOCKED 1. Never try to unblock nozzle with a pin or any other object (as shown in Figure E) . 2. Clean the nozzle as shown below. CLEANING INSTRUCTIONS 1. Gently pull spray nozzle away from bottle (as shown in Figure F) . 2. Rinse SPRAY NOZZLE ONLY under warm water (as shown in Figure G) . 3. Shake or tap to remove excess water. 4. Re-attach spray nozzle to bottle. 5. Press and release spray nozzle until a fine spray is produced, taking care not to spray in face. Triamcinolone Acetonide Nasal Spray, USP pump is now ready to use. Where can I get more information? 1-855-274-4122 Store between 20° to 25°C (68° to 77°F) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016 Issued: 05/2025 SIDE 2 Figure A fig …

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 breastfeeding, 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 (1-800-222-1222) right away.

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

openFDA Drug Labeling

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

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

Active Ingredient

openFDA Drug Labeling

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

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
69168-482-01 69168-482 Allegiant Health 1 BOTTLE in 1 CARTON (69168-482-01) / 120 SPRAY, METERED in 1 BOTTLE July 30, 2025
60505-6275-7 60505-6275 Apotex Corp. 1 BOTTLE, SPRAY in 1 CARTON (60505-6275-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY January 26, 2024
58602-035-07 58602-035 Aurohealth LLC 1 BOTTLE, SPRAY in 1 CARTON (58602-035-07) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY August 11, 2026
58602-035-08 58602-035 Aurohealth LLC 2 BOTTLE, SPRAY in 1 CARTON (58602-035-08) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY August 11, 2026
58602-035-09 58602-035 Aurohealth LLC 3 BOTTLE, SPRAY in 1 CARTON (58602-035-09) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY August 11, 2026
58602-035-10 58602-035 Aurohealth LLC 1 BOTTLE, SPRAY in 1 CARTON (58602-035-10) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY August 11, 2026
12516-1508-0 12516-1508 Bespak HC Limited 189 BOTTLE, SPRAY in 1 CARTON (12516-1508-0) / 16.5 g in 1 BOTTLE, SPRAY October 11, 2013
12516-1509-0 12516-1509 Bespak HC Limited 189 BOTTLE, SPRAY in 1 CARTON (12516-1509-0) / 10.5 g in 1 BOTTLE, SPRAY October 11, 2013
12516-1510-0 12516-1510 Bespak HC Limited 189 BOTTLE, SPRAY in 1 CARTON (12516-1510-0) / 6.5 g in 1 BOTTLE, SPRAY September 7, 2017
70000-0742-1 70000-0742 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 1 BOTTLE, SPRAY in 1 CARTON (70000-0742-1) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY November 26, 2025
67438-045-00 67438-045 Padagis Israel Pharmaceuticals Ltd 120 SPRAY, METERED in 1 BOTTLE (67438-045-00) June 19, 2015
67438-045-01 67438-045 Padagis Israel Pharmaceuticals Ltd 60 SPRAY, METERED in 1 BOTTLE (67438-045-01) October 12, 2016
67438-045-02 67438-045 Padagis Israel Pharmaceuticals Ltd 72 SPRAY, METERED in 1 BOTTLE (67438-045-02) February 28, 2021
67438-045-03 67438-045 Padagis Israel Pharmaceuticals Ltd 144 SPRAY, METERED in 1 BOTTLE (67438-045-03) February 28, 2021
69168-482 69168-482 Allegiant Health — July 30, 2025
60505-6275 60505-6275 Apotex Corp. — January 26, 2024
58602-035 58602-035 Aurohealth LLC — August 11, 2026
12516-1508 12516-1508 Bespak HC Limited — October 11, 2013
12516-1509 12516-1509 Bespak HC Limited — October 11, 2013
12516-1510 12516-1510 Bespak HC Limited — September 7, 2017
70000-0742 70000-0742 CARDINAL HEALTH 110, LLC. DBA LEADER 70000 — November 26, 2025
67438-045 67438-045 Padagis Israel Pharmaceuticals Ltd — June 19, 2015

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 · 11 sections on this page.