Application 021621
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021621-003 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-004 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |
| N021621-007 | CHILDREN'S ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 |
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 | 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 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021621-003 | CHILDREN'S ZYRTEC ALLERGY | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021621-004 | CHILDREN'S ZYRTEC ALLERGY | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021621-005 | CHILDREN'S ZYRTEC HIVES RELIEF | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021621-006 | CHILDREN'S ZYRTEC HIVES RELIEF | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021621-007 | CHILDREN'S ZYRTEC ALLERGY | 2.5MG | TABLET, CHEWABLE / ORAL | RLD | 2020-11-30 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Zyrtec | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | dc613bd5-70fd-1d9b-e053-2995a90a41cd | 2026-04-27 | Warnings | 021621 NDA021621 50580-753 |
| Childrens Zyrtec | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 0fe77356-d945-46a0-882e-b3bbab784556 | 2026-04-22 | Warnings | 021621 NDA021621 50580-791 |
| Childrens Zyrtec | CETIRIZINE HYDROCHLORIDE | A-S Medication Solutions | 0adb3617-3528-4d64-a9ad-b4545ec9d7b9 | 2025-04-08 | Warnings | 021621 NDA021621 |
| Childrens Zyrtec | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 013ce40e-37c9-4b84-b530-ed895f60ce0e | 2025-04-07 | Warnings | 021621 NDA021621 50580-790 |
| CHILDRENS ZYRTEC | CETIRIZINE HYDROCHLORIDE | A-S Medication Solutions | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 2025-03-03 | Warnings | 021621 NDA021621 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50580-753 | Zyrtec | Cetirizine Hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-790 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-791 | Childrens Zyrtec | Cetirizine hydrochloride | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85551 | SUPPL | 2026-03-27 |
| 85550 | SUPPL | 2026-03-27 |
| 79428 | SUPPL | 2024-08-16 |
| 79427 | SUPPL | 2024-08-16 |
| 69585 | SUPPL | 2021-12-16 |
| 69584 | SUPPL | 2021-12-16 |
| 65930 | SUPPL | 2021-01-19 |
| 65922 | SUPPL | 2021-01-19 |
| 21759 | SUPPL | 2008-05-21 |
| 5870 | SUPPL | 2007-11-19 |
| 21758 | ORIG | 2004-12-07 |
| 5869 | ORIG | 2004-03-19 |