Home NDC 41167-3513 Xyzal Allergy 24HR
Product NDC 41167-3513
11-digit product format 411673513
Labeler code 41167
Product ID 41167-3513_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5
Type HUMAN OTC DRUG
Nonproprietary name Levocetirizine dihydrochloride
Dosage form TABLET
Route ORAL
Labeler Chattem, Inc.
Application NDA209089
Marketing category NDA
Marketing start 2026-01-01
Substance LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength 5 mg/1
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 42 .
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 N209089-001 XYZAL ALLERGY 24HR LEVOCETIRIZINE DIHYDROCHLORIDE 5MG TABLET / ORAL RLD, RS 2017-01-31
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 · 42 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 2026-08-18 06:07:40 2026-07 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209089-001 XYZAL ALLERGY 24HR 5MG TABLET / ORAL RLD, RS 2017-01-31 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Xyzal Allergy 24HR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOD6A38AGA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855172 Internal RxNorm lookup 855174 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 41167-3513-4 Xyzal Allergy 24HR 90 in 1 BLISTER PACK TABLET 90 14 41167-3513-4 Xyzal Allergy 24HR 1 in 1 CARTON TABLET 1 14
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 41167-3513-4 41167351304 1 BLISTER PACK in 1 CARTON (41167-3513-4) / 90 TABLET in 1 BLISTER PACK 1 blister pack 2026-01-01 No No Current