Home NDC 50580-721 Childrens Zyrtec Allergy
Product NDC 50580-721
11-digit product format 505800721
Labeler code 50580
Product ID 50580-721_48bb7dd3-c2b8-ecfb-e063-6294a90af77d
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Kenvue Brands LLC
Application NDA022155
Marketing category NDA
Marketing start 2009-01-20
Substance CETIRIZINE HYDROCHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022155-001 CHILDREN'S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 N022155-002 CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022155-001 CHILDREN'S ZYRTEC HIVES 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SOLUTION / ORAL RLD, RS 2007-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022155-001 CHILDREN'S ZYRTEC HIVES RELIEF 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022155-002 CHILDREN'S ZYRTEC ALLERGY 5MG/5ML SYRUP / ORAL RLD, RS 2007-11-16 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Zyrtec Allergy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64O047KTOA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014673 Internal RxNorm lookup 1020021 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-721-05 Childrens Zyrtec Allergy 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 10 50580-721-05 Childrens Zyrtec Allergy 1 in 1 CARTON SYRUP 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Cetirizine Hydrochloride ACTIVE INGREDIENT 64O047KTOA CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 Cetirizine ACTIVE MOIETY YO7261ME24 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-721 CHILDRENS ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20250515_ee8695ac-1293-4e43-ac7c-a64e21a0ca0a.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-721-05 50580072105 1 BOTTLE, PLASTIC in 1 CARTON (50580-721-05) / 118 mL in 1 BOTTLE, PLASTIC 2015-07-13 0000-00-00 No No Current