Cetirizine Hydrochloride
- Product NDC
- 0121-4780
- 11-digit product format
- 001214780
- Labeler code
- 0121
- Product ID
- 0121-4780_4a1a8f26-6fea-49cd-85cc-9e7ea7e7eee8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA090300
- Marketing category
- ANDA
- Marketing start
- 2009-09-15
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 0121-4780 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 0121-4780 | 0121-4780-05 | D | Discontinued by firm | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0121-4780-05 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | I | Inactivated by FDA | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 0121-4780-05 | I | Inactivated by FDA | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | ||
| A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 |
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 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-10-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090300-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090300-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-10-10 | 782e0a99824c… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-4780-05 | 2023-06-15 | C162847 | 48780-1 | 956f9ecf-c4d4-621f-e053-dbdaa90a74ad | Cetirizine Hydrochloride Syrup |
| 0121-4780-05 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c4d4-621f-e053-dbdaa90a74ad | Cetirizine Hydrochloride Syrup |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-4780-05 | ML - Milliliter | 0121-4780 | 4b1603cf-c537-4c33-9ae1-e5ad460b01a1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] | 1 |