Zyrtec Allergy

Manufacturer: Kenvue Brands LLC
Effective date: 2025-10-10
Label type: HUMAN OTC DRUG LABEL
Version: 25
Source: full-release
Hydrated at: 2026-06-01 01:39:13

Label at a glance#

ProductZyrtec Allergy

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure10 sections

Indications and 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

Dosage and administration

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing meets USP Dissolution Test 2

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 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, watery eyes
itching of the nose or throat

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)
do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-726-71

ZYRTEC ^®
ALLERGY

Cetirizine HCl tablets
10 mg /antihistamine

Indoor & Outdoor Allergies

Strength 10mg Tablets

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets
10 mg each

Actual Size

Zyrtec-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	25
1020026	ZyrTEC 10 MG Oral Tablet	PSN	25
1020026	cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]	SBD	25
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	25
1014678	cetirizine HCl 10 MG Oral Tablet	SY	25
1020026	Zyrtec (cetirizine dihydrochloride 10 MG) Oral Tablet	SY	25
1020026	Zyrtec 10 MG Oral Tablet	SY	25

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0312547204361	GTIN-13: 0312547204361 EAN-13: 0312547204361 GTIN-12: 312547204361 UPC-A: 312547204361 GTIN storage (14 digits): 00312547204361	Zyrtec-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-726-03	Zyrtec Allergy	50 in 1 CARTON	TABLET, FILM COATED	50	25
50580-726-03	Zyrtec Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	25
50580-726-05	Zyrtec Allergy	50 in 1 CARTON	TABLET, FILM COATED	50	25
50580-726-05	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-13	Zyrtec Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	25
50580-726-13	Zyrtec Allergy	3 in 1 CARTON	TABLET, FILM COATED	3	25
50580-726-25	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-25	Zyrtec Allergy	2500 in 1 CASE	TABLET, FILM COATED	2500	25
50580-726-30	Zyrtec Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	25
50580-726-30	Zyrtec Allergy	5 in 1 PACKAGE	TABLET, FILM COATED	5	25
50580-726-32	Zyrtec Allergy	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	25
50580-726-32	Zyrtec Allergy	14 in 1 PACKAGE	TABLET, FILM COATED	14	25
50580-726-36	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-36	Zyrtec Allergy	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	25
50580-726-38	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-38	Zyrtec Allergy	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	25
50580-726-40	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-40	Zyrtec Allergy	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	25
50580-726-45	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-45	Zyrtec Allergy	45 in 1 BOTTLE	TABLET, FILM COATED	45	25
50580-726-50	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-50	Zyrtec Allergy	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	25
50580-726-51	Zyrtec Allergy	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	25
50580-726-51	Zyrtec Allergy	2 in 1 PACKAGE	TABLET, FILM COATED	2	25
50580-726-66	Zyrtec Allergy	75 in 1 PACKAGE, COMBINATION	TABLET, FILM COATED	75	25
50580-726-70	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-70	Zyrtec Allergy	70 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	70	25
50580-726-71	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-71	Zyrtec Allergy	30 in 1 BOTTLE	TABLET, FILM COATED	30	25
50580-726-72	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-72	Zyrtec Allergy	40 in 1 BOTTLE	TABLET, FILM COATED	40	25
50580-726-73	Zyrtec Allergy	60 in 1 BOTTLE	TABLET, FILM COATED	60	25
50580-726-73	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-74	Zyrtec Allergy	90 in 1 BOTTLE	TABLET, FILM COATED	90	25
50580-726-74	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-75	Zyrtec Allergy	1 in 1 CARTON	TABLET, FILM COATED	1	25
50580-726-75	Zyrtec Allergy	75 in 1 BOTTLE	TABLET, FILM COATED	75	25
50580-726-90	Zyrtec Allergy	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	25
50580-726-90	Zyrtec Allergy	2 in 1 PACKAGE	TABLET, FILM COATED	2	25
50580-726-91	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-91	Zyrtec Allergy	2500 in 1 CARTON	TABLET, FILM COATED	2500	25
50580-726-92	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-92	Zyrtec Allergy	50 in 1 TRAY	TABLET, FILM COATED	50	25
50580-726-93	Zyrtec Allergy	3 in 1 CARTON	TABLET, FILM COATED	3	25
50580-726-93	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-94	Zyrtec Allergy	60 in 1 BOTTLE	TABLET, FILM COATED	60	25
50580-726-94	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-95	Zyrtec Allergy	90 in 1 BOTTLE	TABLET, FILM COATED	90	25
50580-726-95	Zyrtec Allergy	1 in 1 PACKAGE	TABLET, FILM COATED	1	25
50580-726-96	Zyrtec Allergy	5 in 1 CARTON	TABLET, FILM COATED	5	25
50580-726-96	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-97	Zyrtec Allergy	1 in 1 POUCH	TABLET, FILM COATED	1	25
50580-726-97	Zyrtec Allergy	14 in 1 CARTON	TABLET, FILM COATED	14	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-726-30	EA - Each	50580-726	853bd501-594a-43ba-8d6e-e570fc3ab764	1	2012-07-24
50580-726-32	EA - Each	50580-726	075b55b7-dbdc-464a-b6a4-6071a07901fc	1	2012-07-24
50580-726-36	EA - Each	50580-726	4159f1d6-19ba-4c79-8ede-b5d73ee883fb	1	2012-07-24
50580-726-38	EA - Each	50580-726	6ad75859-5196-4c44-a976-8da28a0c95e9	1	2012-07-24
50580-726-51	EA - Each	50580-726	a2ed8aaf-f19c-4a7e-8aff-41d2a0f3ec96	1	2012-07-24
50580-726-93	EA - Each	50580-726	c0eb6ce2-976c-4e27-af1f-c011ac402eb8	1	2018-10-11
50580-726-96	EA - Each	50580-726	82123398-20e6-4b44-bba9-0c664a14a66e	1	2022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	3
Cetirizine	ACTIVE MOIETY	YO7261ME24	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	3
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	3
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	3
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	3

Products#

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

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

Zyrtec Allergy
Cetirizine Hydrochloride
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-726	50580-726-03, 50580-726-13, 50580-726-30, 50580-726-32, 50580-726-36, 50580-726-50, 50580-726-51, 50580-726-38, 50580-726-70, 50580-726-90, 50580-726-66, 50580-726-40, 50580-726-91, 50580-726-92, 50580-726-93, 50580-726-94, 50580-726-95, 50580-726-96, 50580-726-97, 50580-726-05, 50580-726-25, 50580-726-71, 50580-726-72, 50580-726-73, 50580-726-74, 50580-726-45, 50580-726-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
24	2025-06-25	full-release	2026-06-01 01:06:00

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 4 · 196 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL	166 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Croscarmellose Sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL	330 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED / ORAL	968 mg	Exact identifier — unii+route+dosage form 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 28 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019835-003	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-004	ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD, RS	2007-11-16
N019835-005	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	RLD	2007-11-16
N019835-006	ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RLD	2007-11-16

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 5 · 176 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	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-005	ZYRTEC HIVES	5MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019835-006	ZYRTEC HIVES	10MG	TABLET / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-003	ZYRTEC ALLERGY	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-004	ZYRTEC ALLERGY	10MG	TABLET / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-005	ZYRTEC HIVES RELIEF	5MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019835-006	ZYRTEC HIVES RELIEF	10MG	TABLET / ORAL	RLD	2007-11-16	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	b165db38-b302-4220-8627-77cb07bb078c	2025-10-10	Warnings	Exact identifier ndc (package): 50580-726-40 ndc (package): 50580-726-96 ndc (package): 50580-726-91 ndc (package): 50580-726-05 ndc (package): 50580-726-13 ndc (package): 50580-726-71 ndc (package): 50580-726-94 ndc (package): 50580-726-70 ndc (package): 50580-726-50 ndc (package): 50580-726-03 ndc (package): 50580-726-95 ndc (package): 50580-726-51 ndc (package): 50580-726-25 ndc (package): 50580-726-74 ndc (package): 50580-726-90 ndc (package): 50580-726-75 ndc (package): 50580-726-32 ndc (package): 50580-726-36 ndc (package): 50580-726-72 ndc (package): 50580-726-73 ndc (package): 50580-726-45 ndc (package): 50580-726-30 ndc (package): 50580-726-93 ndc (package): 50580-726-66 ndc (package): 50580-726-92 ndc (package): 50580-726-38 ndc (package): 50580-726-97 ndc (product): 50580-726 ndc11 (package): 50580072630 ndc11 (package): 50580072638 ndc11 (package): 50580072673 ndc11 (package): 50580072645 ndc11 (package): 50580072666 ndc11 (package): 50580072674 ndc11 (package): 50580072670 ndc11 (package): 50580072651 ndc11 (package): 50580072650 ndc11 (package): 50580072692 ndc11 (package): 50580072640 ndc11 (package): 50580072603 ndc11 (package): 50580072613 ndc11 (package): 50580072694 ndc11 (package): 50580072690 ndc11 (package): 50580072625 ndc11 (package): 50580072697 ndc11 (package): 50580072695 ndc11 (package): 50580072605 ndc11 (package): 50580072696 ndc11 (package): 50580072672 ndc11 (package): 50580072675 ndc11 (package): 50580072636 ndc11 (package): 50580072693 ndc11 (package): 50580072671 ndc11 (package): 50580072632 ndc11 (package): 50580072691 spl id: 40cb0300-d3f3-4a66-e063-6394a90a41dc spl set id: b165db38-b302-4220-8627-77cb07bb078c
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	6685a843-9dbe-4f9e-b75b-fe0e258f4155	2025-10-08	Warnings	Exact identifier ndc (package): 50580-726-70 ndc (package): 50580-726-50 ndc11 (package): 50580072670 ndc11 (package): 50580072650

Reported adverse events (FAERS/openFDA)#

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