Cetirizine Hydrochloride
- Product NDC
- 0781-1684
- 11-digit product format
- 007811684
- Labeler code
- 0781
- Product ID
- 0781-1684_2ca4b053-0031-4a34-a1b1-8eaadb0879c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA077946
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2007-12-27 | ||
| A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077946-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2007-12-27 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077946-002 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2007-12-27 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- 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#
| Identifier | FDA.report destination |
|---|---|
| 1014678 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 760dd0e4-280a-4d95-8938-cecaa7ec75f2 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0781-1684-01 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 0781-1684-64 | Cetirizine Hydrochloride | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-1684-01 | EA - Each | 0781-1684 | 28943ae8-5fc1-4c27-838e-4a6a41d31b34 | 1 | 2014-10-03 |
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 |
|---|---|---|---|---|---|---|
| All Day Allergy Relief | CETIRIZINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 76ec3257-9206-4a0f-a2cf-8a05217b92e7 | 2025-07-01 | Warnings | 077946 ANDA077946 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Sandoz Inc | 760dd0e4-280a-4d95-8938-cecaa7ec75f2 | 2013-06-03 | Warnings | 077946 ANDA077946 0781-1684 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 10f3966d-9cb8-4beb-b384-6b2428e92c22 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 760dd0e4-280a-4d95-8938-cecaa7ec75f2 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | dd37b7c4-00d6-4a69-8213-713db5725e7c | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 10f3966d-9cb8-4beb-b384-6b2428e92c22 | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 760dd0e4-280a-4d95-8938-cecaa7ec75f2 | 3 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | dd37b7c4-00d6-4a69-8213-713db5725e7c | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 10f3966d-9cb8-4beb-b384-6b2428e92c22 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 760dd0e4-280a-4d95-8938-cecaa7ec75f2 | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | dd37b7c4-00d6-4a69-8213-713db5725e7c | 3 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b | 2 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b | 2 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 8a2e62ed-3f4b-4a4f-9774-95dd4f014e6b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-1684-01 | 00781168401 | 100 TABLET in 1 BOTTLE (0781-1684-01) | 100 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |
| 0781-1684-64 | 00781168464 | 30 TABLET in 1 BOX, UNIT-DOSE (0781-1684-64) | 30 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |