FDA.reportPublic FDA data

ZYRTEC Allergy

Manufacturer
Kenvue Brands LLC
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:39:44

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 capsule once daily; do not take more than one 10 mg capsule 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°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

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

Warnings

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

Other information

STORAGE AND HANDLING SECTION

  • store between 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

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 50580-786-13

ZYRTEC ®

ALLERGY

Cetirizine HCl capsules

10 mg/antihistamine

Indoor &

Outdoor

Allergies

Strength

10 mg Capsules

LIQUID GELS*
24 Hour relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

12 Liquid-Filled Capsules

10 mg each

Dye-Free

Actual Size

12 *LIQUID-FILLED

CAPSULES

zyrtec-1zyrtec-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN6
1020023ZyrTEC 10 MG Oral CapsulePSN6
1020023cetirizine hydrochloride 10 MG Oral Capsule [Zyrtec]SBD6
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD6
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY6
1020023Zyrtec (cetirizine dihydrochloride 10 MG) Oral CapsuleSY6
1020023Zyrtec 10 MG Oral CapsuleSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450204318GTIN-13: 0300450204318
EAN-13: 0300450204318
GTIN-12: 300450204318
UPC-A: 300450204318
GTIN storage (14 digits): 00300450204318		zyrtec-1.jpg
Data codeData Matrix30059223zyrtec-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-786-12ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-12ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-13ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-13ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-40ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-40ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-41ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-41ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-65ZYRTEC Allergy65 in 1 PACKAGE, COMBINATIONCAPSULE, LIQUID FILLED656
50580-786-66ZYRTEC Allergy65 in 1 PACKAGECAPSULE, LIQUID FILLED656

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-78650580-786-12, 50580-786-25, 50580-786-40, 50580-786-65, 50580-786-13, 50580-786-26, 50580-786-41, 50580-786-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MANNITOL3OWL53L36AIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIM
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-06-12full-release2026-06-01 01:03:11

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213105-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2020-09-21

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2184e616aacf4f…
2026-08-18 06:07:402026-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYRTEC AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC0face45c-af24-3559-e063-6294a90abde52025-10-21WarningsExact identifier
ndc (package): 50580-786-25
ndc (package): 50580-786-40
ndc (package): 50580-786-41
ndc (package): 50580-786-66
ndc (package): 50580-786-65
ndc (package): 50580-786-12
ndc (package): 50580-786-26
ndc (package): 50580-786-13
ndc (product): 50580-786
ndc11 (package): 50580078665
ndc11 (package): 50580078625
ndc11 (package): 50580078641
ndc11 (package): 50580078626
ndc11 (package): 50580078666
ndc11 (package): 50580078612
ndc11 (package): 50580078613
ndc11 (package): 50580078640
spl id: 41a5a9a1-61a6-f771-e063-6294a90aed87
spl set id: 0face45c-af24-3559-e063-6294a90abde5

Reported adverse events (FAERS/openFDA)#

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