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Budesonide
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Budesonide | 32 ug/1 | 1797929 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 078949-001 | BUDESONIDE | SPRAY, METERED | BUDESONIDE | Prescription | — | ||
| 078949-002 | BUDESONIDE | SPRAY, METERED | BUDESONIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 10 | Labeling | Approved | October 29, 2019 | Standard |
| Supplement | 3 | Labeling | Approved | November 20, 2015 | Standard |
| Original application | 1 | Approved | May 12, 2014 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260227). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing
Purpose
openFDA Drug LabelingPurpose Nasal allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingDirection Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for two days 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 6 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 yours 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 times 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 under 6 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 two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use
Warnings
openFDA Drug LabelingWarnings Do not use in children under 6 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 two weeks 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 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 LabelingDo not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients
Ask a Doctor
openFDA Drug LabelingAsk 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 LabelingStop 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 persistent fever you have any change in vision you have severe or frequent nosebleeds
Active Ingredient
openFDA Drug LabelingActive ingredient (in each spray) Budesonide (glucocorticoid) 32 mcg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: BUDESONIDE. 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 60505-6129-2 | 60505-6129 | Apotex Corp. | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6129-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | April 19, 2016 |
| 60505-6129-6 | 60505-6129 | Apotex Corp. | 2 BOTTLE, SPRAY in 1 CARTON (60505-6129-6) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | April 19, 2016 |
| 60505-6129-7 | 60505-6129 | Apotex Corp. | 3 BOTTLE, SPRAY in 1 CARTON (60505-6129-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | April 19, 2016 |
| 69842-001-01 | 69842-001 | CVS Pharmacy | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (69842-001-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | July 1, 2025 |
| 49035-703-01 | 49035-703 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | July 1, 2025 |
| 0536-1112-48 | 0536-1112 | Rugby Laboratories | 1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | July 27, 2016 |
| 0536-1456-84 | 0536-1456 | Rugby Laboratories | 1 BOTTLE, SPRAY in 1 CARTON (0536-1456-84) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | December 1, 2025 |
| 0363-0048-01 | 0363-0048 | Walgreens | 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY | July 1, 2025 |
| 60505-6129 | 60505-6129 | Apotex Corp. | — | April 19, 2016 |
| 69842-001 | 69842-001 | CVS Pharmacy | — | July 1, 2025 |
| 49035-703 | 49035-703 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | — | July 1, 2025 |
| 0536-1112 | 0536-1112 | Rugby Laboratories | — | July 27, 2016 |
| 0536-1456 | 0536-1456 | Rugby Laboratories | — | December 1, 2025 |
| 0363-0048 | 0363-0048 | Walgreens | — | July 1, 2025 |
Sources for 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.