cetirizine hydrochloride
- Product NDC
- 59746-286
- Requested package NDC
- 59746-286-32
- 11-digit product format
- 597460286
- Labeler code
- 59746
- Product ID
- 59746-286_1735144c-74fa-4815-ac46-7a6b1fc8b1eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cetirizine hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA091116
- Marketing category
- ANDA
- Marketing start
- 2015-02-19
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 package | package | 59746-286 | 59746-286-32 | I | Inactivated by FDA | 2026-10-05 |
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… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | ||
| A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | ||
| A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | ||
| A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091116-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091116-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091116-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091116-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-19 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59746-286-32 | 2023-01-30 | C162847 | 48780-1 | f386c649-f3a7-0266-e053-dadaa90a7c1a | Childrens's Cetirizine Hydrochloride Chewable Tablets Antihistamine DRUG FACTS |
| 59746-286-33 | 2023-01-30 | C162847 | 48780-1 | f386c649-cbc3-0266-e053-dadaa90a7c1a | Children's Cetirizine Hydrochloride Chewable Tablets Antihistamine Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59746-286-32 | cetirizine hydrochloride | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 3 | |
| 59746-286-32 | cetirizine hydrochloride | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 3 | |
| 59746-286-33 | cetirizine hydrochloride | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | 2 | |
| 59746-286-33 | cetirizine hydrochloride | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59746-286-32 | EA - Each | 59746-286 | 3debc694-8a05-4f4b-ab1d-e63647ea6431 | 1 | 2017-09-11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59746-286 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 3 | Legacy NDC, 2 package rows | 20200725_3bbe5549-5678-a6ec-d854-2201cfe2bc76.zip |
| 59746-286 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.] | 2 | Legacy NDC, 2 package rows | 20191231_fd6dac8a-e66a-63bd-6c26-23f7dfe00215.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014674 | cetirizine HCl 10 MG Chewable Tablet | PSN | 3bbe5549-5678-a6ec-d854-2201cfe2bc76 | 3 |
| 1014643 | cetirizine HCl 5 MG Chewable Tablet | PSN | 3bbe5549-5678-a6ec-d854-2201cfe2bc76 | 3 |
| 1014674 | cetirizine hydrochloride 10 MG Chewable Tablet | SCD | 3bbe5549-5678-a6ec-d854-2201cfe2bc76 | 3 |
| 1014643 | cetirizine hydrochloride 5 MG Chewable Tablet | SCD | 3bbe5549-5678-a6ec-d854-2201cfe2bc76 | 3 |
| 1014674 | cetirizine HCl 10 MG Chewable Tablet | PSN | fd6dac8a-e66a-63bd-6c26-23f7dfe00215 | 2 |
| 1014643 | cetirizine HCl 5 MG Chewable Tablet | PSN | fd6dac8a-e66a-63bd-6c26-23f7dfe00215 | 2 |
| 1014674 | cetirizine hydrochloride 10 MG Chewable Tablet | SCD | fd6dac8a-e66a-63bd-6c26-23f7dfe00215 | 2 |
| 1014643 | cetirizine hydrochloride 5 MG Chewable Tablet | SCD | fd6dac8a-e66a-63bd-6c26-23f7dfe00215 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59746-286-32 | 59746028632 | 3 BLISTER PACK in 1 CARTON (59746-286-32) > 10 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2015-02-19 | 0000-00-00 | No | No | Current |