ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS

Manufacturer: Wockhardt USA LLC. | Wockhardt Limited | Patheon Puerto Rico, Inc.
Effective date: 2022-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 21:42:30

Label at a glance#

ProductALLERGY 24-HR

Active ingredientFEXOFENADINE HYDROCHLORIDE

Label structure10 sections

Dosage and administration

For 30 mg: adults and children 12 years of 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 For 60 m...

Storage and handling

safety sealed: do not use if carton is opened or if inner seal imprinted with "Sealed for Your Protection" is missing or torn safety sealed: do not use if carton is opened or if individual blister unit is torn or open store between 20° and 25°C (68° and 77°F) protect from excessive moisture

Contacts and useful links#

PhoneLabel contact1-800-346-6854

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

Fexofenadine HCl 180 mg

OTC - PURPOSE SECTION

Antihistamine

USAGE

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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.

OTC - 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For 30 mg:

adults and children 12 years of 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

For 60 mg:

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

For 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 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

STORAGE AND HANDLING SECTION

safety sealed: do not use if carton is opened or if inner seal imprinted with "Sealed for Your Protection" is missing or torn
safety sealed: do not use if carton is opened or if individual blister unit is torn or open
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

For 30 mg

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

For 60 mg

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

For 180 mg

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-346-6854

SPL UNCLASSIFIED SECTION

Manufactured by:

Patheon Puerto Rico, Inc.,

Manati, PR 00674

Distributed by:

Wockhardt USA LLC

20 Waterview Blvd.

Parippany, NJ 07054

USA.

Rev.06-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

30 tablets bottle pack

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

90 tablets bottle pack

Fexofenadine hydrochloride

Film-coated Tablets

Indoor and Outdoor Allergies – 24 hours

180 mg

5 tablets blister carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64679-744-09	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-982-09	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-05	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-10	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-11	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-14	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-17	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-20	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-22	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-24	2025-12-12	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-744-09	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-982-09	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-05	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-10	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-11	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-14	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-17	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-20	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-22	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS
64679-987-24	2024-01-30	C162847	48780-1	1030e365-3768-111a-e063-dadaa90a10e2	ALLERGY 24-HOUR FEXOFENADINE HYDROCHLORIDE TABLETS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-744	ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.]	8	Legacy NDC	20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip
64679-982	ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.]	8	Legacy NDC	20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip
64679-987	ALLERGY 24-HR (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [WOCKHARDT USA LLC.]	8	Legacy NDC	20221230_f4b394a6-8b4d-41ac-8962-82e81d85dd90.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-982-09	EA - Each	64679-982	28da3e73-c4fd-42a9-abab-a1075057b922	1	2015-06-09
64679-987-09	EA - Each	64679-987	a99e9d5d-19a7-4aef-9f24-6195937041c5	1	2015-06-09
64679-987-10	EA - Each	64679-987	18963b59-d80d-44ac-8692-7f082dd65e43	1	2015-06-09
64679-987-11	EA - Each	64679-987	ef2c085c-61ce-4dfc-9320-f02f47381b91	1	2015-06-09
64679-987-12	EA - Each	64679-987	99dbc750-13a9-42b0-85b7-a995830794f8	1	2015-06-09
64679-987-13	EA - Each	64679-987	021e3a5d-fc06-4e43-9a62-a9afe30feb03	1	2015-06-09
64679-987-16	EA - Each	64679-987	19834fc4-eb77-40ea-b275-f3bbba76485e	1	2019-07-02
64679-987-17	EA - Each	64679-987	22a99016-8654-4ff0-9b21-a0a527bacb48	1	2016-03-04
64679-987-20	EA - Each	64679-987	f05034d8-bd1e-435e-913b-edfbc159f336	1	2016-03-04
64679-987-24	EA - Each	64679-987	87da958d-cb9f-406e-988f-f65346a5b794	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FEXOFENADINE HYDROCHLORIDE	ACTIVE INGREDIENT	2S068B75ZU	2
FEXOFENADINE	ACTIVE MOIETY	E6582LOH6V	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

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

ALLERGY 24-HR
FEXOFENADINE HYDROCHLORIDE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
FEXOFENADINE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64679-982	64679-982-08, 64679-982-09
64679-987	64679-987-09, 64679-987-10, 64679-987-11, 64679-987-05, 64679-987-12, 64679-987-20, 64679-987-16, 64679-987-24, 64679-987-13, 64679-987-14, 64679-987-17, 64679-987-22
64679-744	64679-744-08, 64679-744-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FEXOFENADINE HYDROCHLORIDE	2S068B75ZU	ACTIB

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 6 · 318 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / RESPIRATORY (INHALATION)		25 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INSERT / VAGINAL		2282 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED / ORAL		245 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INHALANT / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER, FOR SOLUTION / ORAL		2832 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	45 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	750 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE / ORAL		8946 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, DELAYED RELEASE PARTICLES / ORAL		70 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	FILM / SUBLINGUAL		7 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, CHEWABLE / ORAL		245 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, DELAYED RELEASE / ORAL		227 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-08
A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET / ORAL	2012-02-08
A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-08
A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET / ORAL	2012-02-08
A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-08
A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET / ORAL	2012-02-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-005	FEXOFENADINE HYDROCHLORIDE HIVES	180MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079112-006	FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	TABLET / ORAL	2012-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-001	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-002	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-003	FEXOFENADINE HYDROCHLORIDE HIVES	60MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079112-004	FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG	TABLET / ORAL	2012-02-08	`b8a1b40f171c…`

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
45bfc32c-1b57-898a-e063-6394a90aa930			f4b394a6-8b4d-41ac-8962-82e81d85dd90	2025-12-12	Warnings	Exact identifier spl set id: f4b394a6-8b4d-41ac-8962-82e81d85dd90

Reported adverse events (FAERS/openFDA)#

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