Childrens Allegra Allergy

Manufacturer: Chattem, Inc.
Effective date: 2025-02-18
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 00:55:19

Label at a glance#

ProductChildrens Allegra Allergy

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat

Dosage and administration

place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 12 years of age and over take 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 6 years of age do not use adults 65 years of age and older ask...

Contacts and useful links#

PhoneLabel contact1-800-633-1610

Websitewww.allegra.com

www.allegra.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Fexofenadine HCI 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

runny nose
sneezing
itchy, water eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

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 have

OTC - ASK DOCTOR SECTION

kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not take more than directed
do not take at the same time as aluminum or magnesium antacids
do not take with fruit juices (see Directions)

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

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

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 12 years of age and over	take 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 6 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

phenylketonurics: contains phenylalanine 3.8 mg per tablet
safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20^º and 25^ºC (68^º and 77^ºF)
use tablet immediately after opening individual blister
contains lactose

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, crospovidone, flavors, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-633-1610 or www.allegra.com

Dist. By: Chattem, Inc, a Sanofi Company,

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4232-1
NON-DROWSY
Children’s
Allegra^®
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
12 Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL NDC 41167-4232-1 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Or...

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4232-6
NON-DROWSY
Children’s
Allegra^®
Allergy
fexofenadine HCl orally disintegrating
tablet 30 mg/antihistamine
Indoor and Outdoor Allergies
Orange Cream flavor
24 Orally Disintegrating Tablets

PRINCIPAL DISPLAY PANEL NDC 41167-4232-6 NON-DROWSY Children’s Allegra® Allergy fexofenadine HCl orally disintegrating tablet 30 mg/antihistamine Indoor and Outdoor Allergies Or...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997484	Childrens Allegra Allergy 30 MG Disintegrating Oral Tablet	PSN	16
997482	fexofenadine HCl 30 MG Disintegrating Oral Tablet	PSN	16
997484	fexofenadine hydrochloride 30 MG Disintegrating Oral Tablet [Allegra]	SBD	16
997482	fexofenadine hydrochloride 30 MG Disintegrating Oral Tablet	SCD	16
997484	Allegra 30 MG Disintegrating Oral Tablet	SY	16

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FEXOFENADINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-4232-1	Childrens Allegra Allergy	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	16
41167-4232-1	Childrens Allegra Allergy	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2	16
41167-4232-6	Childrens Allegra Allergy	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6	16
41167-4232-6	Childrens Allegra Allergy	4 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	4	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-4232	CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]	16	Current NDC, Legacy NDC, 4 package rows	20250216_06115cea-5a44-409d-85ed-bb71743491c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-4232-1	EA - Each	41167-4232	6d240a7a-34be-4ec9-8d4e-64c16914377c	1	2014-07-02
41167-4232-6	EA - Each	41167-4232	ade41b16-b68e-4f99-accc-afc2032c3798	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	6
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	6
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	6
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	6

Products#

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

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

Childrens Allegra Allergy
Fexofenadine Hydrochloride
FEXOFENADINE
ASPARTAME
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-4232	41167-4232-1, 41167-4232-6

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
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
ASPARTAME	Z0H242BBR1	IACT
CROSPOVIDONE	2S7830E561	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	NX76LV5T8J	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

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
N021909-002	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2011-01-24
N021909-003	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2011-01-24

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 3 · 86 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	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021909-002	CHILDREN'S ALLEGRA ALLERGY	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021909-003	CHILDREN'S ALLEGRA HIVES	30MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2011-01-24	`74a2ff9319b5…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021909-002	6723348	2021-11-26	U-1466	Drug product	2013-12-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021909-003	6723348	2021-11-26		Drug product	2013-12-18	`ea99ee380514…`

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
Childrens Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	06115cea-5a44-409d-85ed-bb71743491c1	2025-02-18	Warnings	Exact identifier ndc (package): 41167-4232-1 ndc (package): 41167-4232-6 ndc (product): 41167-4232 ndc11 (package): 41167423201 ndc11 (package): 41167423206 spl id: 44cdb5d9-8c36-41e1-af5a-35983ab0cc52 spl set id: 06115cea-5a44-409d-85ed-bb71743491c1

Reported adverse events (FAERS/openFDA)#

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