Cetirizine Hydrochloride Tablets (Allergy)

Manufacturer: Aurohealth LLC | APL HEALTHCARE LIMITED | Aurobindo Pharma Limited
Effective date: 2026-08-03
Label type: Human OTC Drug Label
Version: 12
Source: daily-update
Hydrated at: 2026-08-18 02:02:10

Label at a glance#

ProductCetirizine Hydrochloride (Allergy)

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure19 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

For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6...

Storage and handling

store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

For 5 mg:

Cetirizine hydrochloride USP 5 mg

For 10 mg:

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

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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.
in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

Stop use and ask a 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

If breast-feeding: not recommended
if pregnant: 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. [1-800-222-1222]

Directions

DOSAGE & ADMINISTRATION SECTION

For 5 mg:

adults and children 6 years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
adults 65 years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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)
TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

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 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown,
East Windsor, NJ 08520

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-444-09

^*Compare to the active
ingredient of Zyrtec^®

Original Prescription Strength

Allergy Relief
Cetirizine Hydrochloride
Tablets USP 5 mg

Antihistamine

Indoor & Outdoor Allergies
5 mg Strength Tablets

24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-444-21

^*Compare to the active
ingredient of Zyrtec^®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 5 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
5 mg Strength Tablets

24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10 x 10)
Unit-dose Tablets
5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-445-09

^*Compare to the active
ingredient of Zyrtec^®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength

Indoor & Outdoor Allergies
10 mg Strength Tablets

24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-445-21

^*Compare to the active
ingredient of Zyrtec^®

Allergy Relief
Cetirizine Hydrochloride Tablets USP 10 mg
Antihistamine
Original Prescription Strength
Indoor & Outdoor Allergies
10 mg Strength Tablets

24 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

100 (10x10)Tablets
10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58602-445-09	EA - Each	58602-445	eb8537b0-77ad-44b0-9d7f-b1a2af8c51db	1	2020-02-13
58602-445-40	EA - Each	58602-445	74cf527a-e023-424f-8699-e5a6f5a77950	1	2022-08-04
58602-445-94	EA - Each	58602-445	938c84cc-f01e-403e-a5d2-8e4fd5da694e	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

Cetirizine Hydrochloride (Allergy)
Cetirizine Hydrochloride
CETIRIZINE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58602-444	58602-444-09, 58602-444-17, 58602-444-47, 58602-444-41, 58602-444-21
58602-445	58602-445-09, 58602-445-17, 58602-445-47, 58602-445-15, 58602-445-19, 58602-445-94, 58602-445-38, 58602-445-40, 58602-445-41, 58602-445-21, 58602-445-01, 58602-445-60, 58602-445-54, 58602-445-65, 58602-445-23, 58602-445-39
58602-812	58602-812-09, 58602-812-17, 58602-812-99, 58602-812-23, 58602-812-39, 58602-812-41, 58602-812-83, 58602-812-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
11	2024-09-13	full-release	2026-06-01 00:19:34

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 5 · 256 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 / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL	193 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
HYPROMELLOSE 2910 (5 MPA.S)	HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	TABLET / ORAL	1200 mg	Exact identifier — unii+route+dosage form 32 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 32 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
A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-08-05
A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-08-05
A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-08-05
A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-08-05

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	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2015-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090760-004	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET / ORAL	2015-08-05	`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
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25	2026-08-03	Warnings	Exact identifier ndc (package): 58602-445-15 ndc (package): 58602-444-09 ndc (package): 58602-812-99 ndc (package): 58602-444-41 ndc (package): 58602-445-21 ndc (package): 58602-812-17 ndc (package): 58602-445-39 ndc (package): 58602-444-21 ndc (package): 58602-445-09 ndc (package): 58602-445-47 ndc (package): 58602-812-83 ndc (package): 58602-445-41 ndc (package): 58602-445-60 ndc (package): 58602-812-23 ndc (package): 58602-812-41 ndc (package): 58602-445-19 ndc (package): 58602-812-39 ndc (package): 58602-445-01 ndc (package): 58602-445-65 ndc (package): 58602-812-09 ndc (package): 58602-444-17 ndc (package): 58602-445-94 ndc (package): 58602-445-38 ndc (package): 58602-444-47 ndc (package): 58602-812-04 ndc (package): 58602-445-17 ndc (package): 58602-445-40 ndc (package): 58602-445-23 ndc (package): 58602-445-54 ndc (product): 58602-444 ndc (product): 58602-812 ndc (product): 58602-445 ndc11 (package): 58602044523 ndc11 (package): 58602044547 ndc11 (package): 58602044540 ndc11 (package): 58602044409 ndc11 (package): 58602044538 ndc11 (package): 58602081223 ndc11 (package): 58602044447 ndc11 (package): 58602044594 ndc11 (package): 58602044565 ndc11 (package): 58602044519 ndc11 (package): 58602044554 ndc11 (package): 58602081217 ndc11 (package): 58602044521 ndc11 (package): 58602081204 ndc11 (package): 58602081299 ndc11 (package): 58602044417 ndc11 (package): 58602081209 ndc11 (package): 58602044541 ndc11 (package): 58602044441 ndc11 (package): 58602044509 ndc11 (package): 58602081239 ndc11 (package): 58602044501 ndc11 (package): 58602044517 ndc11 (package): 58602081241 ndc11 (package): 58602044515 ndc11 (package): 58602044560 ndc11 (package): 58602044539 ndc11 (package): 58602081283 ndc11 (package): 58602044421 spl id: 09cf1596-6539-44ff-9f90-a0fb1f218b4e spl set id: 3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25

Reported adverse events (FAERS/openFDA)#

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