Allergy Relief
- Product NDC
- 70000-0148
- Requested package NDC
- 70000-0148-4
- 11-digit product format
- 700000148
- Labeler code
- 70000
- Product ID
- 70000-0148_4b22220b-b524-449f-a865-61f6ac4b39a2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health (Leader) 70000
- Application
- ANDA078780
- Marketing category
- ANDA
- Marketing start
- 2016-09-30
- Marketing end
- 2023-12-31
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 70000-0148 | 70000-0148-4 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-01-21 | ||
| A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-01-21 | ||
| A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2010-01-21 | ||
| A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-01-21 |
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 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078780-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2010-01-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078780-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2010-01-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078780-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2010-01-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078780-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2010-01-21 | d8e5a09893c0… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0148-1 | EA - Each | 70000-0148 | 7da74e67-5629-4e29-8add-3e4e497635f1 | 1 | 2017-06-15 |
| 70000-0148-2 | EA - Each | 70000-0148 | 94bb6593-5dbf-4a38-a7ac-950f44bc4574 | 1 | 2017-05-04 |
| 70000-0148-3 | EA - Each | 70000-0148 | f55e9e51-e3a3-402c-8363-8c4fd88e4479 | 1 | 2017-05-04 |
| 70000-0148-4 | EA - Each | 70000-0148 | 5f51fb53-67a7-485d-ba45-e5e8486765af | 1 | 2017-05-04 |
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 | P & L Development, LLC | a042d98d-35ad-4d40-8b27-79dafd028096 | 2025-08-18 | Warnings | 078780 ANDA078780 |
| Allergy Relief All Day | CETIRIZINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 27548729-7e2e-44cd-9a1d-70744f8b1df6 | 2025-07-01 | Warnings | 078780 ANDA078780 |
| Cetirizine Hydrochloride Hives Relief | CETIRIZINE | Amneal Pharmaceuticals LLC | aad39214-5bf1-427b-a00e-410224c51c95 | 2024-10-23 | Warnings | 078780 ANDA078780 |
| Cetirizine Hydrochloride | CETIRIZINE | Amneal Pharmaceuticals LLC | 214936a2-adc4-422a-a8fe-4c3ce9e01f36 | 2024-07-31 | Warnings | 078780 ANDA078780 |
| Cetirizine Hydrochloride | CETIRIZINE | Amneal Pharmaceuticals LLC | 273172b2-9aaf-46fb-a1ce-2961650eacd3 | 2024-07-31 | Warnings | 078780 ANDA078780 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70000-0148-4 | 70000014804 | 1 BOTTLE, PLASTIC in 1 BOX (70000-0148-4) > 90 TABLET in 1 BOTTLE, PLASTIC | 2016-09-30 | 2023-12-31 | No | No | Current |