Home NDC 70000-0215-1 Leader Childrens all day allergy
Product NDC 70000-0215
Requested package NDC 70000-0215-1
11-digit product format 700000215
Labeler code 70000
Product ID 70000-0215_4adfb8b5-ab2e-42de-beda-76bc865afadd
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application ANDA204226
Marketing category ANDA
Marketing start 2017-02-10
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 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2013-09-09
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 2 · 43 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 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SYRUP / ORAL 2013-09-09 f41ea6bd6efb…
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 Leader Childrens all day allergy
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014673 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 70000-0215-1 Leader Childrens all day allergy 118 mL in 1 BOTTLE SOLUTION 118 4 70000-0215-1 Leader Childrens all day allergy 1 in 1 CARTON SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0215 LEADER CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] 4 Current NDC, Legacy NDC, 2 package rows 20250501_6e69ba49-a487-445b-b5f3-5e468d86ac44.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 3 · 45 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0215-1 70000021501 1 BOTTLE in 1 CARTON (70000-0215-1) / 118 mL in 1 BOTTLE 1 bottle 2017-02-10 0000-00-00 No No Current