cetirizine hydrochloride
- Product NDC
- 50090-4173
- 11-digit product format
- 500904173
- Labeler code
- 50090
- Product ID
- 50090-4173_47910875-0f88-46f7-a5c8-7ef532e211e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cetirizine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090254
- Marketing category
- ANDA
- Marketing start
- 2008-04-15
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 50090-4173 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 50090-4173 | 50090-4173-0 | I | Inactivated by FDA | 2026-08-10 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-4173-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-4173-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-4173-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-4173-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-4173-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-4173-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-4173-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-4173-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-4173-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-4173-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-4173-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-4173-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-4173-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-4173-0 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-4173-0 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | ||
| A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 |
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 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090254-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090254-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-09 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4173-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-9979-0266-e053-dadaa90a7c1a | Perrigo Children's Cetirizine Hydrochloride Oral Solution 1 mg/mL Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4173-0 | cetirizine hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 50090-4173-0 | cetirizine hydrochloride | 118 mL in 1 BOTTLE | SOLUTION | 118 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4173 | CETIRIZINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190326_2b348ce4-7c6e-488f-a781-17b26a170762.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 | Bryant Ranch Prepack | 0dc5a72f-1cc4-4cfc-a969-0ed781f7aa6f | 2025-04-03 | Warnings | 090254 ANDA090254 |
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | c2cf555d-986c-4e89-ac4f-938e92c418e2 | 2025-01-20 | Warnings | 090254 ANDA090254 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 2b348ce4-7c6e-488f-a781-17b26a170762 | 1 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 2b348ce4-7c6e-488f-a781-17b26a170762 | 1 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 2b348ce4-7c6e-488f-a781-17b26a170762 | 1 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 2b348ce4-7c6e-488f-a781-17b26a170762 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4173-0 | 50090417300 | 1 BOTTLE in 1 CARTON (50090-4173-0) > 118 mL in 1 BOTTLE | 1 bottle | 2019-03-07 | 0000-00-00 | No | No | Current |