Childrens Zyrtec

Manufacturer
Kenvue Brands LLC
Effective date
2025-10-10
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:39:12

Label at a glance#

ProductChildrens Zyrtec
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

use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once d...

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 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

  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter
adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate,sorbitol solution, sucralose

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-730-05

Children's

ZYRTEC
®

ALLERGY

Cetirizine HCl oral solution

1 mg/ml/antihistamine

Indoor & Outdoor Allergies

2 yrs &

older

24
hour
Relief of

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

Dye-Free
Sugar-Free
Alcohol-Free

Grape Flavor

4 fl oz (118 ml)


Dosing Cup Included

Zyrtec-1Zyrtec-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN17
1020021ZyrTEC 5 MG in 5 mL Oral SolutionPSN17
1020021cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]SBD17
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD17
1014673cetirizine HCl 1 MG/ML Oral SyrupSY17
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY17
1020021Children's Zyrtec 5 MG per 5 ML Medicated SpoonSY17
1020021Zyrtec 1 MG/ML Oral SolutionSY17
1020021Zyrtec Children's 5 MG per 5 ML SyrupSY17

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-130300450209269GTIN-13: 0300450209269
EAN-13: 0300450209269
GTIN-12: 300450209269
UPC-A: 300450209269
GTIN storage (14 digits): 00300450209269
Zyrtec-1.jpg

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
50580-730-012024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-012024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-052024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-052024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-062024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-062024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-172024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-172024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-182024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-182024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-192024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-192024-02-06C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-012024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-012024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-052024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-052024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-062024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-062024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-172024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-172024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-182024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-182024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-192024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®
50580-730-192024-01-30C16284748780-11030e365-3f8a-111a-e063-dadaa90a10e2Children's ZYRTEC ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-730-01Childrens Zyrtec30 mL in 1 BOTTLE, PLASTICSYRUP3017
50580-730-01Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-05Childrens Zyrtec118 mL in 1 BOTTLE, PLASTICSYRUP11817
50580-730-05Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-06Childrens Zyrtec2 in 1 PACKAGESYRUP217
50580-730-06Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-17Childrens Zyrtec1 in 1 TRAYSYRUP117
50580-730-17Childrens Zyrtec3 in 1 PACKAGESYRUP317
50580-730-18Childrens Zyrtec1 in 1 CARTONSYRUP117
50580-730-18Childrens Zyrtec2 in 1 PACKAGESYRUP217
50580-730-19Childrens Zyrtec240 mL in 1 BOTTLE, PLASTICSYRUP24017
50580-730-19Childrens Zyrtec1 in 1 CARTONSYRUP117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-730-01ML - Milliliter50580-730022a8af8-db63-49fd-99ba-df2675fe45be12018-08-13
50580-730-04ML - Milliliter50580-7304f38da49-8578-4902-8bd1-42dbfdecf4c912012-07-24
50580-730-05ML - Milliliter50580-730fb30f472-f871-4bae-b3c8-dea4c84974a512015-08-04
50580-730-19ML - Milliliter50580-73010959d4b-38e7-4847-ac59-30c7f8c64cb812023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOA3
CetirizineACTIVE MOIETYYO7261ME243
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL3
propylene glycolINACTIVE INGREDIENT6DC9Q167V33
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU3
sorbitolINACTIVE INGREDIENT506T60A25R3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD43
waterINACTIVE INGREDIENT059QF0KO0R3

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
50580-73050580-730-05, 50580-730-06, 50580-730-01, 50580-730-17, 50580-730-18, 50580-730-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
162025-05-20full-release2026-06-01 01:01:19

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 1 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route+dosage form
7 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii+route+dosage form
7 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSYRUP / ORAL268 mgExact identifier — unii+route+dosage form
7 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022155-001CHILDREN'S ZYRTEC HIVESCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16
N022155-002CHILDREN'S ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1684e616aacf4f…
2026-08-18 06:07:402026-07N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-1674a2ff9319b5…

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
Childrens ZyrtecCETIRIZINE HYDROCHLORIDEKenvue Brands LLC9d8e78ea-af98-4f7c-8db5-044b49582f802025-10-10WarningsExact identifier
ndc (package): 50580-730-05
ndc (package): 50580-730-17
ndc (package): 50580-730-18
ndc (package): 50580-730-06
ndc (package): 50580-730-19
ndc (package): 50580-730-01
ndc (product): 50580-730
ndc11 (package): 50580073005
ndc11 (package): 50580073001
ndc11 (package): 50580073018
ndc11 (package): 50580073019
ndc11 (package): 50580073006
ndc11 (package): 50580073017
spl id: 40cb0507-49ef-8320-e063-6294a90ae39f
spl set id: 9d8e78ea-af98-4f7c-8db5-044b49582f80

Reported adverse events (FAERS/openFDA)#

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