Budesonide

Manufacturer: Rugby Laboratories | Apotex Inc.
Effective date: 2026-02-27
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:47:29

Label at a glance#

ProductBudesonide

Active ingredientBUDESONIDE

Label structure11 sections

Indications and uses

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

Dosage and administration

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 ...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Budesonide (glucocorticoid) 32 mcg

Purpose

OTC - PURPOSE SECTION

Nasal allergy symptom reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

• nasal congestion • runny nose • itchy nose • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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 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 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

Other information

SPL UNCLASSIFIED SECTION

do not use if the safety seal labeled "sealed for your protection" is broken or missing.
keep package and insert. They contain important information.
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-645-2158

Principal Display Panel - Carton 120ms

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Relief of:

Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

Carton-label-120ms

Principal Display Panel - Bottle 120ms

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 32 mcg per spray

Rugby Laboratories NDC 0536-1112-48

Budesonide Nasal Spray

Allergy Spray

120 sprays

Bottle-label-120ms

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	PSN	12
1797929	budesonide 0.032 MG/ACTUAT Metered Dose Nasal Spray	SCD	12
1797929	budesonide 32 MCG/ACTUAT Metered Dose Nasal Spray	SY	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUDESONIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0536-1112-40	Budesonide	1 in 1 CARTON	SPRAY, METERED	1	12
0536-1112-40	Budesonide	60 in 1 BOTTLE, SPRAY	SPRAY, METERED	60	12
0536-1112-48	Budesonide	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120	12
0536-1112-48	Budesonide	1 in 1 CARTON	SPRAY, METERED	1	12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

Budesonide
EDETATE DISODIUM
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
DEXTROSE, UNSPECIFIED FORM
POTASSIUM SORBATE
POLYSORBATE 80
HYDROCHLORIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1112	0536-1112-40, 0536-1112-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUDESONIDE	Q3OKS62Q6X	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078949-002	BUDESONIDE	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL			2015-11-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078949-002	BUDESONIDE	0.032MG/SPRAY	SPRAY, METERED / NASAL	2015-11-20	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Budesonide	BUDESONIDE	Rugby Laboratories	04eb9e98-1323-353f-3fd7-2d317dfac526	2026-02-27	Warnings	Exact identifier ndc (package): 0536-1112-40 ndc (package): 0536-1112-48 ndc (product): 0536-1112 ndc11 (package): 00536111240 ndc11 (package): 00536111248 spl id: ce26c1bb-c50d-7731-6877-0b8a5fda98df spl set id: 04eb9e98-1323-353f-3fd7-2d317dfac526

Reported adverse events (FAERS/openFDA)#

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