Zyrtec Allergy
- Product NDC
- 50580-778
- 11-digit product format
- 505800778
- Labeler code
- 50580
- Product ID
- 50580-778_3254957b-3bb2-98a9-e063-6394a90a9358
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA022578
- Marketing category
- NDA
- Marketing start
- 2014-01-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50580-778 | 50580-778-12 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 50580-778 | 50580-778-66 | D | Discontinued by firm | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50580-778-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 50580-778-66 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50580-778-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 50580-778-66 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50580-778-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 50580-778-66 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50580-778-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 50580-778-66 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50580-778-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 50580-778-66 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50580-778-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 50580-778-66 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50580-778-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 50580-778-66 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50580-778-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 50580-778-66 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50580-778-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 50580-778-66 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50580-778-66 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 50580-778-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 50580-778-66 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 50580-778-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 50580-778-66 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 50580-778-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022578-001 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 |
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 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022578-001 | ZYRTEC ALLERGY | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2010-09-03 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zyrtec Allergy
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 6a962a1c-c197-492b-bfa6-e0c28eda1533 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-778-12 | Zyrtec Allergy | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | 17 | |
| 50580-778-12 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 17 | |
| 50580-778-24 | Zyrtec Allergy | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | 17 | |
| 50580-778-24 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 17 | |
| 50580-778-66 | Zyrtec Allergy | 11 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 11 | 17 | |
| 50580-778-66 | Zyrtec Allergy | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-778-12 | EA - Each | 50580-778 | edad8f68-eb4b-4322-bdfe-ed5b565771ad | 1 | 2015-01-05 |
| 50580-778-24 | EA - Each | 50580-778 | 5a2b0c49-f074-41a1-b5ac-abb39da000c4 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Childrens Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | a1edc2e6-3661-4d7a-884c-709d73cb89e0 | 2025-04-22 | Warnings | 022578 NDA022578 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 2025-04-11 | Warnings | 022578 NDA022578 50580-778 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1011482 | cetirizine HCl 10 MG Disintegrating Oral Tablet | PSN | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
| 1011485 | ZyrTEC 10 MG Disintegrating Oral Tablet | PSN | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
| 1011485 | cetirizine hydrochloride 10 MG Disintegrating Oral Tablet [Zyrtec] | SBD | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
| 1011482 | cetirizine hydrochloride 10 MG Disintegrating Oral Tablet | SCD | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
| 1011482 | cetirizine HCl 10 MG Disintegrating Oral Tablet | SY | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
| 1011485 | Zyrtec 10 MG Disintegrating Oral Tablet | SY | 6a962a1c-c197-492b-bfa6-e0c28eda1533 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-778-12 | 50580077812 | 2 in 1 CARTON | Historical | |||||
| 50580-778-24 | 50580077824 | 4 BLISTER PACK in 1 CARTON (50580-778-24) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 blister pack | 2014-01-20 | 0000-00-00 | No | No | Current |
| 50580-778-66 | 50580077866 | 11 in 1 CARTON | Historical |