Fexofenadine HCl Tablets USP

Manufacturer: Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited (FTO III) | Reed-Lane, Inc.
Effective date: 2026-07-09
Label type: HUMAN OTC DRUG LABEL
Version: 21
Source: daily-update
Hydrated at: 2026-07-17 21:45:38

Label at a glance#

ProductFexofenadine hydrochloride

Active ingredientFexofenadine Hydrochloride

Label structure14 sections

Dosage and administration

30 mg adults and children 12 yearsof age and over take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; 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 60 mg: adults...

Contacts and useful links#

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

INDICATIONS & USAGE SECTION

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

runny nose
itchy, watery eyes
sneezing
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

OTC - WHEN USING SECTION

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 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

30 mg

adults and children 12 yearsof age and over	take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours; 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

60 mg:

adults and children 12 years of age and over	take one 60 mg tablet with water every 12 hours; do not take morethan 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

180 mg:

adults and children 12 years of age and over	take one 180 mg tablet with water once a day; do not take more than1 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 or if printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 mg Container:

180mgcontainer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mg Carton:

carton30mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mg Carton:

60mgcarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mg Container:

60mgcontainer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 mg Carton Label:

180mgcarton

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55111-784-01	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-01	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-05	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-05	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-07	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-07	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-15	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-15	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-18	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-18	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-23	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-23	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-28	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-28	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-29	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-29	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-30	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-30	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-35	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-35	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-40	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-40	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-43	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-43	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-45	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-45	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-59	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-59	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-75	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-75	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-78	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-78	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-90	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP
55111-784-90	2024-01-30	C162847	48780-1	1030e365-28f7-111a-e063-dadaa90a10e2	Fexofenadine HCl Tablets USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-784-01	EA - Each	55111-784	fcfbe779-dfaf-4c1a-b197-12b0a5ca5247	1	2018-12-13
55111-784-30	EA - Each	55111-784	9ca6ce31-a274-408f-b03e-0b74b74bc4fd	1	2015-09-10
55111-783-01	EA - Each	55111-783	a8173485-0ae0-4f47-b1e4-bba599b231c6	1	2021-08-05
55111-783-30	EA - Each	55111-783	094e4978-ddce-4c9c-b387-143de74ef654	1	2021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Fexofenadine Hydrochloride	ACTIVE INGREDIENT	2S068B75ZU	7
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	7
mannitol	INACTIVE INGREDIENT	3OWL53L36A	7
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	7
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	7

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Fexofenadine hydrochloride
FEXOFENADINE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
magnesium stearate
mannitol
POWDERED CELLULOSE
FD&C RED NO. 40
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
polyethylene glycol 400
TITANIUM DIOXIDE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55111-784	55111-784-30, 55111-784-43, 55111-784-40, 55111-784-45, 55111-784-59, 55111-784-75, 55111-784-90, 55111-784-01, 55111-784-15, 55111-784-18, 55111-784-05, 55111-784-23, 55111-784-07, 55111-784-35, 55111-784-29, 55111-784-79, 55111-784-78, 55111-784-28
55111-782	55111-782-30, 55111-782-90, 55111-782-01, 55111-782-79, 55111-782-78
55111-783	55111-783-30, 55111-783-60, 55111-783-90, 55111-783-01, 55111-783-79, 55111-783-78, 55111-783-28, 55111-783-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Fexofenadine Hydrochloride	2S068B75ZU	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
magnesium stearate	70097M6I30	IACT
mannitol	3OWL53L36A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
polyethylene glycol 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
Fexofenadine Hydrochloride	2S068B75ZU	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
magnesium stearate	70097M6I30	IACT
mannitol	3OWL53L36A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
polyethylene glycol 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
Fexofenadine Hydrochloride	2S068B75ZU	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
19	2025-05-06	full-release	2026-06-01 01:00:34

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 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL	7 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET / ORAL	1582 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
mannitol	MANNITOL	3OWL53L36A	TABLET / ORAL	3391 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL	7 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL	7 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
HYPROMELLOSE 2910 (6 MPA.S)	HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	TABLET / ORAL	880 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL	2 mg	Exact identifier — unii+route+dosage form 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 34 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 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076502-001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2006-04-11
A076502-002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2006-04-11
A076502-003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2006-04-11
A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2011-04-12
A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2011-04-12
A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12
A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2011-04-12

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 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2006-04-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2006-04-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2006-04-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2006-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2006-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2006-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL		2006-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL		2006-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL		2006-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-007	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-008	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-009	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL		2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-001	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-002	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-003	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	AB	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL		2011-04-12	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076502-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076502-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076502-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076502-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076502-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076502-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076502-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076502-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076502-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076502-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076502-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076502-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076502-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076502-001	AB	1	`8072bd15b7f6…`

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
Fexofenadine hydrochloride	FEXOFENADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	864e3052-5787-bf11-9d17-11274ca2304f	2026-07-09	Warnings	Exact identifier ndc (package): 55111-784-35 ndc (package): 55111-784-15 ndc (package): 55111-783-90 ndc (package): 55111-782-01 ndc (package): 55111-784-59 ndc (package): 55111-784-28 ndc (package): 55111-784-29 ndc (package): 55111-784-07 ndc (package): 55111-783-28 ndc (package): 55111-782-78 ndc (package): 55111-784-01 ndc (package): 55111-784-18 ndc (package): 55111-783-30 ndc (package): 55111-782-30 ndc (package): 55111-784-30 ndc (package): 55111-783-01 ndc (package): 55111-782-79 ndc (package): 55111-784-45 ndc (package): 55111-784-23 ndc (package): 55111-784-90 ndc (package): 55111-784-43 ndc (package): 55111-784-75 ndc (package): 55111-784-40 ndc (package): 55111-783-79 ndc (package): 55111-783-24 ndc (package): 55111-784-79 ndc (package): 55111-783-60 ndc (package): 55111-782-90 ndc (package): 55111-783-78 ndc (package): 55111-784-78 ndc (package): 55111-784-05 ndc (product): 55111-784 ndc (product): 55111-783 ndc (product): 55111-782 ndc11 (package): 55111078405 ndc11 (package): 55111078423 ndc11 (package): 55111078475 ndc11 (package): 55111078478 ndc11 (package): 55111078278 ndc11 (package): 55111078230 ndc11 (package): 55111078429 ndc11 (package): 55111078435 ndc11 (package): 55111078430 ndc11 (package): 55111078418 ndc11 (package): 55111078330 ndc11 (package): 55111078328 ndc11 (package): 55111078490 ndc11 (package): 55111078324 ndc11 (package): 55111078201 ndc11 (package): 55111078390 ndc11 (package): 55111078378 ndc11 (package): 55111078445 ndc11 (package): 55111078379 ndc11 (package): 55111078440 ndc11 (package): 55111078428 ndc11 (package): 55111078407 ndc11 (package): 55111078401 ndc11 (package): 55111078479 ndc11 (package): 55111078459 ndc11 (package): 55111078415 ndc11 (package): 55111078290 ndc11 (package): 55111078279 ndc11 (package): 55111078443 ndc11 (package): 55111078360 ndc11 (package): 55111078301 spl id: c5d24cd6-8212-e647-78b1-27906e6f62bd spl set id: 864e3052-5787-bf11-9d17-11274ca2304f

Reported adverse events (FAERS/openFDA)#

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