Home NDC 41520-212 All Day Allergy
Product NDC 41520-212
11-digit product format 415200212
Labeler code 41520
Product ID 41520-212_67a5a75a-7a28-4d07-99b4-8325d1776f3a
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Care One (American Sales Company)
Application ANDA205291
Marketing category ANDA
Marketing start 2024-12-31
Substance CETIRIZINE HYDROCHLORIDE
Active strength 10 mg/1
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 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL 2017-07-21
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 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205291-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2017-07-21 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 All Day Allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 10 mg/1
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 1014675 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 41520-212-25 All Day Allergy 1 in 1 BOX CAPSULE, LIQUID FILLED 1 2 41520-212-25 All Day Allergy 25 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-212 ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)] 2 Current NDC, 2 package rows 20250409_01d0729f-11ef-4ec5-8d8e-2863407c3f95.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 Sample Exclude flag Status 41520-212-25 41520021225 1 BOTTLE, PLASTIC in 1 BOX (41520-212-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2024-12-31 No No Current