FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Manufacturer
DIRECT RX
Effective date
2023-01-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:46:13

Label at a glance#

ProductCETIRIZINE HYDROCHLORIDE
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

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.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet) Purpose
Cetirizine HCl 10 mg..............................................................................................Antihistimine

OTC - PURPOSE SECTION

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

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

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact Poison Control Center right away.

OTC - QUESTIONS 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 sever 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

429429

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3
1014678cetirizine HCl 10 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-429-302025-01-30C16284748780-12cef2736-9c50-d83d-e063-dadaa90ab31fCETIRIZINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-429-30CETIRIZINE HYDROCHLORIDE30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-429CETIRIZINE HYDROCHLORIDE TABLET [DIRECT RX]3Legacy NDC, 1 package rows20230113_4445548f-d11c-3c1b-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-402-10EA - Each16571-4022524d8a5-6929-4792-b28d-276f9c97b20e12012-07-24
16571-402-50EA - Each16571-402a6cd2ed0-855f-460d-a2cb-5f7054e8e84912013-02-13
16571-402-90EA - Each16571-402d8ef7ec6-0a15-4216-95b1-e5296fd2d24212012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-42961919-429-30
16571-402

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSES3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT

Source Document#

Source XML

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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077829-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORALRS2009-08-26
A077829-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-08-26

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-09-14 22:38:342026-08A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2684e616aacf4f…
2026-08-18 06:07:402026-07A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-265bbf6a4d5a75…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.5481ccb3-b311-4b25-b923-4fe8522ea92b2025-11-05WarningsExact identifier
ndc (product): 16571-402
f213f0a8-4096-18e3-e053-2995a90a19f24445548f-d11c-3c1b-e054-00144ff8d46c2023-01-12WarningsExact identifier
spl id: f213f0a8-4096-18e3-e053-2995a90a19f2
spl set id: 4445548f-d11c-3c1b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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