Childrens Cetirizine Hydrochloride
- Product NDC
- 51672-2102
- 11-digit product format
- 516722102
- Labeler code
- 51672
- Product ID
- 51672-2102_38f727a4-1153-9087-e063-6294a90ae97b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090182
- Marketing category
- ANDA
- Marketing start
- 2011-09-08
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | ||
| A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 |
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 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2008-04-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090182-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090182-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2008-04-22 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Cetirizine Hydrochloride
- Brand name suffix
- Sugar Free Grape
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64O047KTOA | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1014673 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 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 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-2102-1 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 51672-2102-1 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 240 mL in 1 BOTTLE | SOLUTION | 240 | 6 | |
| 51672-2102-2 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 2 in 1 CARTON | SOLUTION | 2 | 6 | |
| 51672-2102-2 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 120 mL in 1 BOTTLE | SOLUTION | 120 | 6 | |
| 51672-2102-4 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 51672-2102-4 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 60 mL in 1 BOTTLE | SOLUTION | 60 | 6 | |
| 51672-2102-7 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 240 mL in 1 BOTTLE | SOLUTION | 240 | 6 | |
| 51672-2102-7 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 2 in 1 CARTON | SOLUTION | 2 | 6 | |
| 51672-2102-8 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 51672-2102-8 | Childrens Cetirizine Hydrochloride Sugar Free Grape | 120 mL in 1 BOTTLE | SOLUTION | 120 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-2102-8 | ML - Milliliter | 51672-2102 | 9c5ff033-2296-40e3-82ef-17b9cdcc2a1e | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-2102 | CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 10 package rows | 20210422_54d72d7a-1f5b-4b36-bf76-ab7aef6243ab.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab | 6 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab | 6 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab | 6 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 54d72d7a-1f5b-4b36-bf76-ab7aef6243ab | 6 |
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 016b66fd-dde9-4f13-afaf-a8aafbdeed1a | 4 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 016b66fd-dde9-4f13-afaf-a8aafbdeed1a | 4 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 016b66fd-dde9-4f13-afaf-a8aafbdeed1a | 4 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 016b66fd-dde9-4f13-afaf-a8aafbdeed1a | 4 |
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 42a1168e-e2cd-a1e5-e063-6294a90ab3b6 | 1 |
| 1014673 | cetirizine HCl 5 MG in 5 mL Oral Solution | PSN | 582db483-394e-4c00-8522-4041a11696e4 | 1 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 42a1168e-e2cd-a1e5-e063-6294a90ab3b6 | 1 |
| 1014673 | cetirizine hydrochloride 1 MG/ML Oral Solution | SCD | 582db483-394e-4c00-8522-4041a11696e4 | 1 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 42a1168e-e2cd-a1e5-e063-6294a90ab3b6 | 1 |
| 1014673 | cetirizine HCl 1 MG/ML Oral Syrup | SY | 582db483-394e-4c00-8522-4041a11696e4 | 1 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 42a1168e-e2cd-a1e5-e063-6294a90ab3b6 | 1 |
| 1014673 | cetirizine HCl 5 MG per 5 ML Oral Solution | SY | 582db483-394e-4c00-8522-4041a11696e4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-2102-1 | 51672210201 | 1 BOTTLE in 1 CARTON (51672-2102-1) / 240 mL in 1 BOTTLE | 1 bottle | 2011-09-08 | 0000-00-00 | No | No | Current |
| 51672-2102-2 | 51672210202 | 2 BOTTLE in 1 CARTON (51672-2102-2) / 120 mL in 1 BOTTLE | 2 bottle | 2011-09-08 | 0000-00-00 | No | No | Current |
| 51672-2102-4 | 51672210204 | 1 BOTTLE in 1 CARTON (51672-2102-4) / 60 mL in 1 BOTTLE | 1 bottle | 2011-09-08 | 0000-00-00 | No | No | Current |
| 51672-2102-7 | 51672210207 | 2 BOTTLE in 1 CARTON (51672-2102-7) / 240 mL in 1 BOTTLE | 2 bottle | 2011-09-08 | 0000-00-00 | No | No | Current |
| 51672-2102-8 | 51672210208 | 1 BOTTLE in 1 CARTON (51672-2102-8) / 120 mL in 1 BOTTLE | 1 bottle | 2011-09-08 | 0000-00-00 | No | No | Current |