Childrens Zyrtec
- Product NDC
- 50580-791
- 11-digit product format
- 505800791
- Labeler code
- 50580
- Product ID
- 50580-791_500a1503-02c8-cc05-e063-6394a90a24fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA021621
- Marketing category
- NDA
- Marketing start
- 2021-06-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
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ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |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ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |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HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |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HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE / ORAL | RLD | 2007-11-16 | |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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Zyrtec
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64O047KTOA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0fe77356-d945-46a0-882e-b3bbab784556 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-791-01 | Childrens Zyrtec | 4 in 1 CARTON | TABLET, CHEWABLE | 4 | 14 | |
| 50580-791-01 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-02 | Childrens Zyrtec | 8 in 1 CARTON | TABLET, CHEWABLE | 8 | 14 | |
| 50580-791-02 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-03 | Childrens Zyrtec | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 14 | |
| 50580-791-03 | Childrens Zyrtec | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 14 | |
| 50580-791-72 | Childrens Zyrtec | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 14 | |
| 50580-791-72 | Childrens Zyrtec | 24 in 1 BLISTER PACK | TABLET, CHEWABLE | 24 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-791-01 | EA - Each | 50580-791 | 2df7db41-61d7-4756-be60-253c6254843b | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
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 |
| 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 |
| CHILDRENS ZYRTEC | CETIRIZINE HYDROCHLORIDE | A-S Medication Solutions | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 2025-03-03 | Warnings | 021621 NDA021621 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014674 | cetirizine HCl 10 MG Chewable Tablet | PSN | 0fe77356-d945-46a0-882e-b3bbab784556 | 14 |
| 1020022 | ZyrTEC 10 MG Chewable Tablet | PSN | 0fe77356-d945-46a0-882e-b3bbab784556 | 14 |
| 1020022 | cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec] | SBD | 0fe77356-d945-46a0-882e-b3bbab784556 | 14 |
| 1014674 | cetirizine hydrochloride 10 MG Chewable Tablet | SCD | 0fe77356-d945-46a0-882e-b3bbab784556 | 14 |
| 1020022 | Zyrtec 10 MG Chewable Tablet | SY | 0fe77356-d945-46a0-882e-b3bbab784556 | 14 |
| 1014674 | cetirizine HCl 10 MG Chewable Tablet | PSN | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 3 |
| 1020022 | ZyrTEC 10 MG Chewable Tablet | PSN | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 3 |
| 1020022 | cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec] | SBD | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 3 |
| 1014674 | cetirizine hydrochloride 10 MG Chewable Tablet | SCD | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 3 |
| 1020022 | Zyrtec 10 MG Chewable Tablet | SY | 5c19a07e-09f4-46ed-939c-d21fe3e811f6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-791-01 | 50580079101 | 4 BLISTER PACK in 1 CARTON (50580-791-01) / 6 TABLET, CHEWABLE in 1 BLISTER PACK | 4 blister pack | 2021-06-21 | 0000-00-00 | No | No | Current |
| 50580-791-02 | 50580079102 | 8 BLISTER PACK in 1 CARTON (50580-791-02) / 6 TABLET, CHEWABLE in 1 BLISTER PACK | 8 blister pack | 2023-01-01 | 0000-00-00 | No | No | Current |
| 50580-791-03 | 50580079103 | 1 BLISTER PACK in 1 CARTON (50580-791-03) / 6 TABLET, CHEWABLE in 1 BLISTER PACK | 1 blister pack | 2022-09-01 | 0000-00-00 | No | No | Current |
| 50580-791-72 | 50580079172 | 3 BLISTER PACK in 1 CARTON (50580-791-72) / 24 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2024-01-15 | No | No | Current |