FDA.reportPublic FDA data

Cetirizine Hydrochloride - Aurohealth LLC | Aurobindo Pharma Limited

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2026-09-09
Label type
Human OTC Drug Label
Version
6
Source
daily-update
Hydrated at
2026-09-24 01:01:39

Label at a glance#

ProductChildrens Cetirizine Hydrochloride Hives Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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 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) do not use if carton is opened, or if cap safety seal is broken or missing.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION


Cetirizine hydrochloride USP 5 mg

Purpose

OTC - PURPOSE SECTION


Antihistamine

Uses

Indications & Usage Section

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.


Warnings

Warnings Section


Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms: 


  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

OTC - DO NOT USE SECTION

  • to prevent hives from any known cause such as: 
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 


  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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


  • 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 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)
  • do not use if carton is opened, or if cap safety seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION


cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose

Questions?

OTC - QUESTIONS SECTION


call 1-855-274-4122

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

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


AUROHEALTH

NDC 58602-030-24

Children's
Cetirizine Hydrochloride
Oral Solution USP 1 mg/mL
antihistamine

HIVES RELIEF

 24
Hour relief
Reduces Itching
Due to Hives
Reduces Hives

6 yrs &
older

4 fl oz (120 mL)

Cherry Flavor


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


AUROHEALTH

NDC 58602-030-24

*Compare to the active ingredient
in Children's ZYRTEC®

Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine

Hives
Relief
6 yrs &
older

HIVES RELIEF

24 Hour relief
Reduces Itching
Due to Hives
Reduces Hives

Cherry Flavor
4 fl oz (120 mL)

Dosing cup
included


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)




DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA1
CETIRIZINEACTIVE MOIETYYO7261ME241
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9B1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-03058602-030-24, 58602-030-20, 58602-030-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
ACETIC ACIDQ40Q9N063PIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM ACETATE4550K0SC9BIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-09full-release2026-06-01 01:29:40

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / ORAL44 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / ORAL44 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / ORAL44 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / ORAL10 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / ORAL44 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii+route+dosage form
4 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
A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02
A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2010-02-02

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 22:38:342026-08A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-0284e616aacf4f…
2026-08-18 06:07:402026-07A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2010-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2010-02-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090750-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2010-02-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090750-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2010-02-0274a2ff9319b5…

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
95f01d24-5f39-41e2-b6d9-90c4f3fbdffee000848a-8bbe-4149-bdcb-d7b4b0bd4d0d2025-12-09WarningsExact identifier
spl set id: e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d

Reported adverse events (FAERS/openFDA)#

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