Home NDC 59726-063 All Day Allergy Relief
Product NDC 59726-063
11-digit product format 597260063
Labeler code 59726
Product ID 59726-063_8781c73d-663f-4d59-8d9c-df1700ed9a3f
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine HCl
Dosage form CAPSULE
Route ORAL
Labeler P & L Development, LLC
Application ANDA213105
Marketing category ANDA
Marketing start 2021-05-28
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE / ORAL 2020-09-21
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.
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 2026-02-19 14:30 UTC 2026-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213105-001 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG CAPSULE / ORAL 2020-09-21 a50c72e98297…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59726-063 ALL DAY ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [P & L DEVELOPMENT, LLC] 3 Legacy NDC 20241222_b71f3e7f-4024-40d4-b98f-b0a47c68cd26.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 · 16 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59726-063-25 59726006325 1 BOTTLE in 1 BOX (59726-063-25) > 25 CAPSULE in 1 BOTTLE 1 bottle 2021-05-28 0000-00-00 No No Current