Cetirizine
- Product NDC
- 55154-8081
- 11-digit product format
- 551548081
- Labeler code
- 55154
- Product ID
- 55154-8081_47d71250-9b28-4dd0-b913-9bd378c7e223
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2018-06-29
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 | 55154-8081 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 55154-8081 | 55154-8081-0 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2007-12-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078336-004 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55154-8081-0 | Cetirizine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 8 | |
| 55154-8081-0 | Cetirizine | 10 in 1 BAG | TABLET, FILM COATED | 10 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-8081 | CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 4 | Legacy NDC, 2 package rows | 20240627_6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf.zip |
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 |
|---|---|---|---|---|---|---|
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | Proficient Rx LP | 198ca875-bb8a-49d5-8809-7121ba119381 | 2022-04-01 | Warnings | 078336 ANDA078336 |
| rexall all day allergy relief | CETIRIZINE HYDROCHLORIDE | Dolgencorp, LLC | 4d79fb74-1895-4efe-8016-c0dd5ed10f7a | 2021-06-01 | Warnings | 078336 ANDA078336 |
| basic care all day allergy | CETIRIZINE HYDROCHLORIDE | Amazon.com Services LLC | af8ff570-8f72-4343-b7e1-e977221f5b01 | 2021-04-09 | Warnings | 078336 ANDA078336 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf | 8 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf | 8 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 6f3c2e57-7a0f-432f-a7f1-04906f5e4ddf | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-8081-0 | 55154808100 | 10 BLISTER PACK in 1 BAG (55154-8081-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2018-06-29 | 0000-00-00 | No | No | Current |