Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022155
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | None | Yes | Yes |
| CHILDREN'S ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/16/2007 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022155s000ltr_CKD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022155s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/24/2025 | SUPPL-29 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022155Orig1s029ltr.pdf | |
| 11/26/2024 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019835Orig1s050;22155Orig1s027ltr.pdf | |
| 11/13/2024 | SUPPL-25 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022155Orig1s025ltr.pdf | |
| 10/11/2018 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022155Orig1s015Ltr.pdf | |
| 09/10/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2016 | SUPPL-10 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022155Orig1s010ltr.pdf | |
| 05/16/2014 | SUPPL-9 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022155Orig1s009ltr.pdf | |
| 05/22/2012 | SUPPL-7 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022155s007ltr.pdf |
| 03/13/2009 | SUPPL-6 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s006ltr.pdf |
| 03/04/2009 | SUPPL-5 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022155s005ltr.pdf |
| 08/14/2008 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s003ltr.pdf |
| 08/14/2008 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022155s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/24/2025 | SUPPL-29 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s029lbl.pdf |
| 11/26/2024 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019835Orig1s050;22155Orig1s027lbl.pdf | |
| 11/13/2024 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022155Orig1s025lbl.pdf | |
| 10/11/2018 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022155Orig1015Lbl.pdf | |
| 04/14/2016 | SUPPL-10 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022155Orig1s010lbl.pdf |
| 05/16/2014 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022155Orig1s009lbl.pdf |
CHILDREN'S ZYRTEC ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;ORAL; 5MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090474 | APOZEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091327 | BAJAJ |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091130 | CHARTWELL MOLECULAR |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 210622 | HETERO LABS LTD III |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 204226 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 212266 | QUAGEN |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090474 | APOZEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091327 | BAJAJ |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091130 | CHARTWELL MOLECULAR |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | Yes | 022155 | KENVUE BRANDS |
| CHILDREN'S ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | Yes | 022155 | KENVUE BRANDS |
CHILDREN'S ZYRTEC HIVES
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;ORAL; 5MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090474 | APOZEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091327 | BAJAJ |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091130 | CHARTWELL MOLECULAR |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 210622 | HETERO LABS LTD III |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 204226 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 212266 | QUAGEN |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090765 | AMNEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090474 | APOZEAL PHARMS |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090750 | AUROBINDO PHARMA |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091327 | BAJAJ |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 091130 | CHARTWELL MOLECULAR |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090254 | PERRIGO R AND D |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 090182 | TARO |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | No | 201546 | TARO |
| CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | Yes | 022155 | KENVUE BRANDS |
| CHILDREN'S ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Over-the-counter | Yes | 022155 | KENVUE BRANDS |