CETIRIZINE HYDROCHLORIDE

Manufacturer: Northstar Rx LLC | Orchid Pharma Ltd. | Orchid Healthcare (A Division of Orchid Pharma Ltd.)
Effective date: 2020-11-16
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 23:07:09

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure9 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).

Contacts and useful links#

PhoneLabel contact1-800-206-7821

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride USP, 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.

OTC - WHEN USING SECTION

When using this product

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding:

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.

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).

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-206-7821

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-271-02

Cetirizine Hydrochloride Tablets, USP 10 mg

Antihistamine

Allergy

6 Years and Older

24 Hour Relief of:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

NORTHSTAR^TM

100 Tablets 10 mg Each

image description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-271-02	EA - Each	16714-271	66fcf951-746d-43a0-97dc-8b9fd8201958	1	2012-07-24
16714-271-03	EA - Each	16714-271	3151c246-f9cd-4556-83b5-ecf0d3b47a1b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	9
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	9
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	9

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

CETIRIZINE HYDROCHLORIDE
CETIRIZINE
STARCH, CORN
LACTOSE MONOHYDRATE
POVIDONE K29/32
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16714-271	16714-271-02, 16714-271-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
POVIDONE K29/32	390RMW2PEQ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 99 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	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED / ORAL		300 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FOR SUSPENSION / ORAL		2794 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INSERT / VAGINAL		2282 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE / ORAL		3990 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		520 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, DELAYED RELEASE / ORAL		2087 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / SUBCUTANEOUS		98 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL		2575 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	690 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE / ORAL		8946 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / SUBLINGUAL		505 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / ORAL		50 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / BUCCAL		43 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED PELLETS / ORAL		265 mg	Exact identifier — unii candidate 38 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	Approval date
A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19
A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8807545d-1d6b-4360-b7ad-30bf2321766a			d2166bf5-41a2-4592-8428-818f0dad402d	2020-11-16	Warnings	Exact identifier spl id: 8807545d-1d6b-4360-b7ad-30bf2321766a spl set id: d2166bf5-41a2-4592-8428-818f0dad402d

Reported adverse events (FAERS/openFDA)#

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