FDA.reportPublic FDA data

478 - Nasal Spray Azelastine Hydrochloride

Manufacturer
Allegiant Health
Effective date
2025-05-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:39:07

Label at a glance#

ProductAZELASTINE HYDROCHLORIDE
Active ingredientAZELASTINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Read the User Guide for how to: prime the bottle before first use use the spray prime bottle again if not used for 3 or more days clean the spray nozzle if it gets clogged adults and children 12 years and older This product may be used either once or twice a day: once daily: use 2 sprays in each nostril;OR twice daily: use 1 or 2 sprays in each nostril every 12 hours do not use more than 4 spraysin each nostril in...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Azelastine hydrochloride 205.5 mcg (equivalent to 187.6 mcg azelastine)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • nasal congestion
  • runny nose
  • sneezing
  • itchy nose

Warnings

WARNINGS SECTION

Only for use in the nose. Do not spray in eyes or mouth.

Do not use if you have

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have had recent nose ulcers or nose surgery
  • have had nose injury that has not healed

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • you may get a bitter taste in your mouth. To help avoid this, tilt your head downward while spraying.
  • nasal discomfort or sneezing may occur right after use
  • do not share this bottle with anyone else as this may spread germs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction, such as a skin rash, to this product occurs
  • you have severe or frequent nosebleeds

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Read the User Guide for how to:
    • prime the bottle before first use
    • use the spray
    • prime bottle again if not used for 3 or more days
    • clean the spray nozzle if it gets clogged
adults and children 12 years and olderThis product may be used either once or twice a day:
  • once daily: use 2 sprays in each nostril;OR
  • twice daily: use 1 or 2 sprays in each nostril every 12 hours
  • do not use more than 4 spraysin each nostril in a 24 hour period
children 6 years to 11 years
  • an adult should supervise use
  • 1 spray in each nostril every 12 hours
  • do not use more than 2 spraysin each nostril in a 24 hour period
children under 6 yearsdo not use

Other information

SPL UNCLASSIFIED SECTION

  • store between 20°C to 25°C (68°F to 77°F). Protect from freezing
  • keep this carton and the enclosed User Guide for important information
  • do not use if sealed package is torn or opened

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium dihydrate, hypromellose, purified
water, sodium citrate (dihydrate), sorbitol, sucralose

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azelastine hydrochloride labelAzelastine hydrochloride labelAzelastine hydrochloride cartonAzelastine hydrochloride cartonAzelastine hydrochloride insertAzelastine hydrochloride insertAzelastine hydrochloride insertAzelastine hydrochloride insert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSN6
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCD6
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AZELASTINE Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369168478633GTIN-13: 0369168478633
EAN-13: 0369168478633
GTIN-12: 369168478633
UPC-A: 369168478633
GTIN storage (14 digits): 00369168478633		478---nasal-spray-azelastine-hydrochloride-2.jpg
Data codeCode 128467856478---nasal-spray-azelastine-hydrochloride-3.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-478-02AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
69168-478-02AZELASTINE HYDROCHLORIDE2 in 1 CARTONSPRAY, METERED26
69168-478-63AZELASTINE HYDROCHLORIDE120 in 1 BOTTLE, SPRAYSPRAY, METERED1206
69168-478-63AZELASTINE HYDROCHLORIDE1 in 1 CARTONSPRAY, METERED16

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-47869168-478-63, 69168-478-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
AZELASTINE HYDROCHLORIDE0L591QR10IACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-05-02full-release2026-06-01 01:00:17

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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216421-001AZELASTINE HYDROCHLORIDE ALLERGYAZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29
A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGYAZELASTINE HYDROCHLORIDE0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-291e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216421-001AZELASTINE HYDROCHLORIDE ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216421-002AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY0.2055MG/SPRAYSPRAY, METERED / NASAL2024-05-29a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDEAllegiant Health3e2fdb0d-c2f5-41ab-b1cd-4fae806481122025-05-02WarningsExact identifier
ndc (package): 69168-478-02
ndc (package): 69168-478-63
ndc (product): 69168-478
ndc11 (package): 69168047863
ndc11 (package): 69168047802
spl id: fc930f5c-a2b9-4e66-814d-ca8d68cc2d29
spl set id: 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112

Reported adverse events (FAERS/openFDA)#

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