Data updated: Jul 17, 2026
ZYRTEC-D 12 HOUR (cetirizine hydrochloride) · KENVUE BRANDS
Respiratory
Approved 2001-08-10
3
Indications
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2001-08-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
ZYRTEC-D 12 HOUR Approval History
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2001 to 2026 · 2 indication expansions
Mar 2016 SUPPL
Mfg
Aug 2015 SUPPL
Mfg
Feb 2014 SUPPL
Mfg
Oct 2013 SUPPL
Mfg
Feb 2002 SUPPL
Mfg
What ZYRTEC-D 12 HOUR Treats
3 FDA approvalsOriginally approved for its first indication in 2001 . Covers 3 distinct patient populations.
- Other (3)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYRTEC-D 12 HOUR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.