Home NDC 41520-301-26 careone childrens allergy relief
Product NDC 41520-301
Requested package NDC 41520-301-26
11-digit product format 415200301
Labeler code 41520
Product ID 41520-301_b9b6767c-f3bf-4a95-9acd-13a0424d9c4b
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form SOLUTION
Route ORAL
Labeler American Sales Company
Application ANDA204226
Marketing category ANDA
Marketing start 2017-10-09
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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A204226-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2013-09-09 c2088c7a36db…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…
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 careone childrens allergy relief
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 · 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 41520-301-26 careone childrens allergy relief 118 mL in 1 BOTTLE SOLUTION 118 6 41520-301-26 careone childrens allergy relief 1 in 1 CARTON SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-301 CAREONE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [AMERICAN SALES COMPANY] 5 Current NDC, Legacy NDC, 2 package rows 20250512_a4e43301-3e03-4364-b303-645de1697572.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 41520-301-26 41520030126 1 BOTTLE in 1 CARTON (41520-301-26) / 118 mL in 1 BOTTLE 1 bottle 2017-10-09 0000-00-00 No No Current