Children Astepro Allergy

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:20:07

Label at a glance#

ProductChildren Astepro Allergy

Active ingredientAZELASTINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

Read the User Guide for how to: prime the bottle before first use prime bottle again if not used for 3 or more days use the spray 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 sprays in each nostri...

Contacts and useful links#

PhoneLabel contact1-800-317-2165

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Azelastine HCl 205.5 mcg (equivalent to 187.6 mcg azelastine)

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Uses

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

nasal congestion
runny nose
sneezing
itchy nose

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
prime bottle again if not used for 3 or more days
use the spray
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 sprays in 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 sprays in each nostril in a 24 hour period
children under 6 years	do not use

Other information

OTHER SAFETY INFORMATION

Other information

store between 20° to 25° C (68° to 77° F). Protect from freezing.
keep this carton and the enclosed User Guide for important information
do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?

1-800-317-2165 (Mon-Fri, 9AM-5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Childrens Astepro 120Azelastine HCl 205.5 mcg per spray

ANTIHISTAMINE NASAL SPRAY

FULL PRESCRIPTION STRENGTH

STEROID FREE

UP TO 24 HOUR RELIEF OF

Nasal congestion
Runny nose
Sneezing
Itchy nose

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1797884	Astepro 205.5 MCG/ACTUAT Metered Dose Nasal Spray	PSN	7
1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	PSN	7
1797884	azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray [Astepro]	SBD	7
1797883	azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray	SCD	7
1797884	Astepro 0.206 MG/ACTUAT Metered Dose Nasal Spray	SY	7
1797884	Astepro 205.5 MCG/ACTUAT Metered Dose Nasal Spray	SY	7
1797883	azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal Spray	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AZELASTINE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
85ee67c3-6973-4172-9ada-b124d28b42f8	Product name	5	20210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00	Product name	5	20201006
033d5d5b-187f-1f40-1e5a-11d732813f92	Product name	4	20200626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0280-0066-01	Children Astepro Allergy	1 in 1 CARTON	SPRAY, METERED	1	7
0280-0066-01	Children Astepro Allergy	60 in 1 BOTTLE	SPRAY, METERED	60	7
0280-0066-02	Children Astepro Allergy	1 in 1 CARTON	SPRAY, METERED	1	7
0280-0066-02	Children Astepro Allergy	120 in 1 BOTTLE	SPRAY, METERED	120	7
0280-0066-03	Children Astepro Allergy	1 in 1 CARTON	SPRAY, METERED	1	7
0280-0066-03	Children Astepro Allergy	22 in 1 BOTTLE	SPRAY, METERED	22	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0280-0066-01	ML - Milliliter	0280-0066	64923aae-770a-4e2e-9686-8ac20798e56c	1	2022-09-12
0280-0066-02	ML - Milliliter	0280-0066	9e7d587c-58f7-4da0-9579-ecb5a8cd55bc	1	2022-09-12
0280-0066-03	ML - Milliliter	0280-0066	f4bd3aa8-6472-4b52-9505-12accc2793f5	1	2023-10-16

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Children Astepro Allergy
Azelastine HCl
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
HYPROMELLOSES
AZELASTINE HYDROCHLORIDE
AZELASTINE
SODIUM CITRATE
SORBITOL
SUCRALOSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0280-0066	0280-0066-03, 0280-0066-01, 0280-0066-02

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
AZELASTINE HYDROCHLORIDE	0L591QR10I	ACTIB
SODIUM CITRATE	1Q73Q2JULR	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213872-001	ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2021-06-17
N213872-002	CHILDREN'S ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2021-06-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213872-001	8071073	2028-06-04		Drug product	2021-07-08
N213872-002	8071073	2028-06-04		Drug product	2021-07-08

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213872-001	ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213872-002	CHILDREN'S ASTEPRO ALLERGY	0.2055MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-06-17	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 194 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-002	9919050	2025-11-22		Drug product	2021-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-002	9919050	2025-11-22		Drug product	2021-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-002	9919050	2025-11-22		Drug product	2021-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-002	9919050	2025-11-22		Drug product	2021-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-002	9919050	2025-11-22		Drug product	2021-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213872-002	8071073	2028-06-04		Drug product	2021-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-001	8518919	2025-11-22	U-3166		2021-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-001	9919050	2025-11-22		Drug product	2021-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-001	8071073	2028-06-04		Drug product	2021-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213872-002	8518919	2025-11-22	U-3166		2021-07-08	`2680178bc6a6…`

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
Children Astepro Allergy	AZELASTINE HCL	Bayer HealthCare LLC.	e26f9f67-4098-6d2e-e053-2995a90a8598	2025-12-04	Warnings	Exact identifier ndc (package): 0280-0066-03 ndc (package): 0280-0066-02 ndc (package): 0280-0066-01 ndc (product): 0280-0066 ndc11 (package): 00280006601 ndc11 (package): 00280006603 ndc11 (package): 00280006602 spl id: 45263d0f-63fd-7187-e063-6394a90a06c0 spl set id: e26f9f67-4098-6d2e-e053-2995a90a8598

Reported adverse events (FAERS/openFDA)#

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