Allegra Allergy

Manufacturer: Chattem, Inc.
Effective date: 2025-02-19
Label type: HUMAN OTC DRUG LABEL
Version: 19
Source: full-release
Hydrated at: 2026-06-01 00:55:38

Label at a glance#

ProductAllegra Allergy

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure10 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

adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-633-1610

Websitewww.allegra.com

www.allegra.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Allegra Allergy® Gelcaps – 24 HOUR

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Fexofenadine HCI 180 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

adults and children 12 years of age and over	take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 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

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)
protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C red 28, D&C red 33, FD&C blue 1, gelatin, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, PEG-135, pharmaceutical ink, pregelatinized starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Dist. By: Chattem, Inc., a Sanofi Company, Chattanooga, TN 37409-0219 ©2014

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41167-4122-0
Allegra®
ALLERGY
fexofenadine HCI tablet
180 mg/antihistamine
24 HR
8 GELCAPS

NDC 41167-4122-0 Allegra® ALLERGY fexofenadine HCI tablet 180 mg/antihistamine 24 HR 8 GELCAPS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
997422	Allegra 180 MG Oral Tablet	PSN	19
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	PSN	19
997422	fexofenadine hydrochloride 180 MG Oral Tablet [Allegra]	SBD	19
997420	fexofenadine hydrochloride 180 MG Oral Tablet	SCD	19
997422	Allegra 180 MG Oral Tablet	SY	19
997420	fexofenadine HCl 180 MG 24 HR Oral Tablet	SY	19

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
41167-4122-0	Allegra Allergy	8 in 1 BLISTER PACK	TABLET, COATED	8	19
41167-4122-0	Allegra Allergy	1 in 1 CARTON	TABLET, COATED	1	19
41167-4122-2	Allegra Allergy	60 in 1 BOTTLE	TABLET, COATED	60	19
41167-4122-2	Allegra Allergy	1 in 1 CARTON	TABLET, COATED	1	19
41167-4122-5	Allegra Allergy	24 in 1 BOTTLE	TABLET, COATED	24	19
41167-4122-5	Allegra Allergy	1 in 1 CARTON	TABLET, COATED	1	19
41167-4122-6	Allegra Allergy	32 in 1 BOTTLE	TABLET, COATED	32	19
41167-4122-6	Allegra Allergy	1 in 1 CARTON	TABLET, COATED	1	19
41167-4122-7	Allegra Allergy	40 in 1 BOTTLE	TABLET, COATED	40	19
41167-4122-9	Allegra Allergy	2 in 1 CARTON	TABLET, COATED	2	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-4122	ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, COATED [CHATTEM, INC.]	19	Current NDC, Legacy NDC, 10 package rows	20250221_f061d6b1-89f7-4d5f-ac59-9c73408517c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41167-4122-0	EA - Each	41167-4122	3a35f0a5-0516-4e29-a8f2-88da4f8235ce	1	2018-03-08
41167-4122-2	EA - Each	41167-4122	2518db29-f05b-49ba-a278-8aa86851b903	1	2017-05-03
41167-4122-5	EA - Each	41167-4122	f8d82f4f-f62c-48b9-b277-51aac0b33b2d	1	2022-09-12
41167-4122-6	EA - Each	41167-4122	7928dbf2-5442-4ea3-a8ce-e360da62ca5d	1	2022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	5
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	5
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	5

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Allegra Allergy
Fexofenadine Hydrochloride
FEXOFENADINE
CROSCARMELLOSE SODIUM
D&C RED NO. 28
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 6000
STARCH, CORN
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41167-4122	41167-4122-5, 41167-4122-6, 41167-4122-7, 41167-4122-9, 41167-4122-2, 41167-4122-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 3 · 140 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 63 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SOLUTION / ORAL		3 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SUSPENSION / ORAL	0.7 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, COATED / ORAL	NA		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SUSPENSION / ORAL	0.7 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SOLUTION / ORAL		3 mg	Exact identifier — unii+route 63 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SOLUTION / ORAL		3 mg	Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 63 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, COATED / ORAL	106 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SUSPENSION / ORAL	0.7 mg/5ml		Exact identifier — unii+route 63 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii+route 63 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 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020872-005	CHILDREN'S ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24
N020872-006	CHILDREN'S ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	RLD	2011-01-24
N020872-007	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-008	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	RLD	2011-01-24
N020872-009	ALLEGRA HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	2011-01-24
N020872-010	ALLEGRA ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	RLD, RS	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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-009	ALLEGRA HIVES	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020872-010	ALLEGRA ALLERGY	180MG	TABLET / ORAL	RLD, RS	2011-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-005	CHILDREN'S ALLEGRA ALLERGY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-006	CHILDREN'S ALLEGRA HIVES	30MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-007	ALLEGRA ALLERGY	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020872-008	ALLEGRA HIVES	60MG	TABLET / ORAL	RLD	2011-01-24	`fd3edfee7708…`

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
Allegra Allergy	FEXOFENADINE HYDROCHLORIDE	Chattem, Inc.	f061d6b1-89f7-4d5f-ac59-9c73408517c1	2025-02-19	Warnings	Exact identifier ndc (package): 41167-4122-6 ndc (package): 41167-4122-2 ndc (package): 41167-4122-9 ndc (package): 41167-4122-0 ndc (package): 41167-4122-5 ndc (package): 41167-4122-7 ndc (product): 41167-4122 ndc11 (package): 41167412206 ndc11 (package): 41167412202 ndc11 (package): 41167412205 ndc11 (package): 41167412200 ndc11 (package): 41167412207 ndc11 (package): 41167412209 spl id: 9bcf6745-5989-41ba-beef-1108fcecc020 spl set id: f061d6b1-89f7-4d5f-ac59-9c73408517c1

Reported adverse events (FAERS/openFDA)#

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