ZYRTEC
- Product NDC
- 50580-779
- 11-digit product format
- 505800779
- Labeler code
- 50580
- Product ID
- 50580-779_cea20e63-c9ab-38c7-e053-2995a90adebe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Application
- NDA022429
- Marketing category
- NDA
- Marketing start
- 2010-02-08
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 50580-779 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 50580-779 | 50580-779-12 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50580-779 | 50580-779-25 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50580-779 | 50580-779-40 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 50580-779 | 50580-779-65 | D | Discontinued by firm | 2026-10-05 |
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 | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50580-779 | 50580-779-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50580-779 | 50580-779-40 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50580-779 | 50580-779-65 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | |
| N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-779-12 | EA - Each | 50580-779 | 55b1fc91-dfc4-4ca8-a5a1-405e3b8597d5 | 1 | 2012-07-24 |
| 50580-779-25 | EA - Each | 50580-779 | 59492dd0-fb59-4646-b8f9-a56adc90fa01 | 1 | 2012-07-24 |
| 50580-779-40 | EA - Each | 50580-779 | 3e06abb1-99ed-408a-8c0e-493ed2211462 | 1 | 2012-07-24 |
| 50580-779-65 | EA - Each | 50580-779 | 35e610c2-8d04-4dbc-b125-36130d203206 | 1 | 2012-07-24 |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-779-12 | 50580077912 | 1 BOTTLE in 1 PACKAGE (50580-779-12) > 12 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-25 | 50580077925 | 1 BOTTLE in 1 PACKAGE (50580-779-25) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-40 | 50580077940 | 1 BOTTLE in 1 PACKAGE (50580-779-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-65 | 50580077965 | 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-779-65) | 2010-02-08 | 0000-00-00 | No | No | Current |