Allegra Allergy — Tablet, Film Coated

Overview

Brand name

Allegra Allergy

Generic name

fexofenadine hydrochloride

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

NDA · NDA

Labeler

Chattem, Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

7

Packages

18

Data completeness

82% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Fexofenadine Hydrochloride	180 mg/1	997501	View
Fexofenadine Hydrochloride	60 mg/1	997501	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated

Route of administration

Oral

Presentations

25

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Histamine H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

020872

Application type

NDA · New Drug Application

Approval date

February 25, 2000

Sponsor

CHATTEM SANOFI

Products on application

6

Submissions recorded

26

Products approved under application 020872.
Product	Trade name	Form	Ingredient	Status	TE	Flags
020872-005	CHILDREN'S ALLEGRA ALLERGY	TABLET	FEXOFENADINE HYDROCHLORIDE	Discontinued	—	RLD
020872-006	CHILDREN'S ALLEGRA HIVES	TABLET	FEXOFENADINE HYDROCHLORIDE	Discontinued	—	RLD
020872-007	ALLEGRA ALLERGY	TABLET	FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—	RLD
020872-008	ALLEGRA HIVES	TABLET	FEXOFENADINE HYDROCHLORIDE	Discontinued	—	RLD
020872-009	ALLEGRA HIVES	TABLET	FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—	RLD RS
020872-010	ALLEGRA ALLERGY	TABLET	FEXOFENADINE HYDROCHLORIDE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 020872.
Type	No.	Action	Status	Date	Review
Supplement	47	Manufacturing (CMC)	Approved	August 1, 2023	Standard
Supplement	46	Labeling	Approved	October 13, 2021	Standard
Supplement	38	Labeling	Approved	May 10, 2016	Standard
Supplement	37	Manufacturing (CMC)	Approved	March 23, 2016	Standard
Supplement	35	Manufacturing (CMC)	Approved	September 24, 2015	Standard
Supplement	36	Manufacturing (CMC)	Approved	September 18, 2015	Standard
Supplement	33	Manufacturing (CMC)	Approved	December 2, 2014	Standard
Supplement	32	Labeling	Approved	September 12, 2014	Standard
Supplement	31	Manufacturing (CMC)	Approved	April 16, 2014	Standard
Supplement	30	Manufacturing (CMC)	Approved	April 16, 2013	Standard
Supplement	29	Labeling	Approved	August 23, 2012	Standard
Supplement	25	Labeling	Approved	February 23, 2012	Unknown
Supplement	23	Efficacy	Approved	January 24, 2011	Standard
Supplement	18	Labeling	Approved	June 25, 2008	Standard
Supplement	15	Efficacy	Approved	October 13, 2005	Unknown
Supplement	11	Efficacy	Approved	May 12, 2003	Priority
Supplement	3	Efficacy	Approved	May 12, 2003	Standard
Supplement	9	Manufacturing (CMC)	Approved	December 10, 2002	Standard
Supplement	10	Manufacturing (CMC)	Approved	October 10, 2002	Standard
Supplement	8	Manufacturing (CMC)	Approved	February 20, 2002	Standard
Supplement	7	Labeling	Approved	July 11, 2001	Standard
Supplement	4	Manufacturing (CMC)	Approved	May 30, 2001	Standard
Supplement	5	Manufacturing (CMC)	Approved	January 5, 2001	Standard
Supplement	1	Manufacturing (CMC)	Approved	April 14, 2000	Standard
Supplement	2	Manufacturing (CMC)	Approved	March 21, 2000	Standard
Original application	1	Type 3 - New Dosage Form	Approved	February 25, 2000	Standard

Review documents

0 · Supplement · August 2, 2023
0 · Supplement · August 2, 2023
0 · Supplement · October 29, 2021
0 · Supplement · October 14, 2021
0 · Supplement · May 20, 2016
0 · Supplement · May 12, 2016
0 · Supplement · May 12, 2016
0 · Supplement · September 23, 2014
0 · Supplement · September 16, 2014
0 · Supplement · August 6, 2014
0 · Supplement · April 17, 2014
0 · Supplement · November 26, 2013
0 · Supplement · November 13, 2012
0 · Supplement · August 27, 2012
0 · Supplement · March 27, 2012
0 · Supplement · February 27, 2012
0 · Supplement · January 27, 2011
0 · Supplement · August 4, 2008
0 · Supplement · August 1, 2008
0 · Supplement · August 1, 2008
0 · Supplement · August 1, 2008
0 · Supplement · June 30, 2008
0 · Supplement · June 30, 2008
0 · Supplement · October 19, 2005
0 · Supplement · October 19, 2005
0 · Supplement · May 26, 2004
0 · Supplement · May 26, 2004
0 · Original application · May 26, 2004
0 · Supplement · May 26, 2004
0 · Supplement · June 8, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260422). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260422 HUMAN OTC DRUG · 20260414 HUMAN OTC DRUG · 20240730

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Allegra 12 Hour Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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

Allegra 24 Hour Directions 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

Warnings

openFDA Drug Labeling

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have 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 an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) 12 Hour Tablet: Fexofenadine HCl 60 mg 24 Hour Tablet: Fexofenadine HCl 180 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-1234 NDC: 50090-1234-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC / 1 in a CARTON Product: 50090-1235 Product: 50090-1845

Adverse event reports

Source: openFDA FAERS

21,660

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FEXOFENADINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-1234-0	50090-1234	A-S Medication Solutions	1 BOTTLE, PLASTIC in 1 CARTON (50090-1234-0) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	November 28, 2014
41167-4120-0	41167-4120	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-4120-0) / 5 TABLET, FILM COATED in 1 BLISTER PACK	March 3, 2011
41167-4120-2	41167-4120	Chattem, Inc.	3 BLISTER PACK in 1 CARTON (41167-4120-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK	March 3, 2011
41167-4120-3	41167-4120	Chattem, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (41167-4120-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	March 3, 2011
41167-4120-4	41167-4120	Chattem, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (41167-4120-4) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	March 3, 2011
41167-4120-6	41167-4120	Chattem, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (41167-4120-6) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	March 3, 2011
41167-4121-1	41167-4121	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4121-1) / 60 TABLET, FILM COATED in 1 BOTTLE	June 1, 2021
41167-4121-4	41167-4121	Chattem, Inc.	1 BOTTLE, PLASTIC in 1 CARTON (41167-4121-4) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	March 3, 2011
41167-4124-0	41167-4124	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4124-0) / 90 TABLET, FILM COATED in 1 BOTTLE	December 1, 2020
41167-4124-3	41167-4124	Chattem, Inc.	2 BOTTLE in 1 PACKAGE (41167-4124-3) / 55 TABLET, FILM COATED in 1 BOTTLE (41167-4124-5)	October 1, 2020
41167-4124-8	41167-4124	Chattem, Inc.	1 BOTTLE in 1 CARTON (41167-4124-8) / 100 TABLET, FILM COATED in 1 BOTTLE	May 1, 2022
41167-4131-2	41167-4131	Chattem, Inc.	1 BLISTER PACK in 1 CARTON (41167-4131-2) / 12 TABLET, FILM COATED in 1 BLISTER PACK	March 3, 2011
41167-4131-4	41167-4131	Chattem, Inc.	2 BLISTER PACK in 1 CARTON (41167-4131-4) / 12 TABLET, FILM COATED in 1 BLISTER PACK	March 3, 2011
41167-4131-6	41167-4131	Chattem, Inc.	3 BLISTER PACK in 1 CARTON (41167-4131-6) / 12 TABLET, FILM COATED in 1 BLISTER PACK	March 2, 2019
66715-9707-1	66715-9707	Lil' Drug Store Products, Inc	1 BLISTER PACK in 1 CARTON (66715-9707-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK	November 1, 2018
66715-9707-2	66715-9707	Lil' Drug Store Products, Inc	2 BLISTER PACK in 1 CARTON (66715-9707-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK	November 1, 2018
66715-9707-8	66715-9707	Lil' Drug Store Products, Inc	5 BLISTER PACK in 1 CARTON (66715-9707-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK	November 1, 2018
67751-033-02	67751-033	Navajo Manufacturing Company Inc.	1 BLISTER PACK in 1 CARTON (67751-033-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK	March 31, 2016
50090-1234	50090-1234	A-S Medication Solutions	—	March 3, 2011
41167-4120	41167-4120	Chattem, Inc.	—	March 3, 2011
41167-4121	41167-4121	Chattem, Inc.	—	March 3, 2011
41167-4124	41167-4124	Chattem, Inc.	—	October 1, 2020
41167-4131	41167-4131	Chattem, Inc.	—	March 3, 2011
66715-9707	66715-9707	Lil' Drug Store Products, Inc	—	September 1, 2014
67751-033	67751-033	Navajo Manufacturing Company Inc.	—	May 12, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.