CHILDRENS CETIRIZINE HYDROCHLORIDE

Product NDC
51672-2148
11-digit product format
516722148
Labeler code
51672
Product ID
51672-2148_137524f7-318b-4772-9ce7-97593c7ad2a7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
TARO PHARMACEUTICALS U.S.A., INC.
Application
ANDA201546
Marketing category
ANDA
Marketing start
2022-06-29
Marketing end
0000-00-00
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
2023-12-31
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-2148IInactivated by FDA2026-08-10
excluded packagepackage51672-214851672-2148-1IInactivated by FDA2026-08-10
excluded packagepackage51672-214851672-2148-8IInactivated by FDA2026-08-10

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.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-2148-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-2148-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-2148-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-2148-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51672-2148-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51672-2148-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51672-2148-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51672-2148-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51672-2148-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51672-2148-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51672-2148-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51672-2148-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51672-2148-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51672-2148-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51672-2148-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51672-2148-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51672-2148-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51672-2148-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51672-2148-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51672-2148-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51672-2148-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51672-2148-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51672-2148-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51672-2148-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51672-2148-88af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51672-2148-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51672-2148-8834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51672-2148-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51672-2148-81332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51672-2148-11332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2011-05-20
A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2011-05-20

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2011-05-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2011-05-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201546-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2011-05-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A201546-002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2011-05-20782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2148-1CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM240 mL in 1 BOTTLESOLUTION2402
51672-2148-1CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM1 in 1 CARTONSOLUTION12
51672-2148-8CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM1 in 1 CARTONSOLUTION12
51672-2148-8CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM120 mL in 1 BOTTLESOLUTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2148CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE BUBBLE GUM (CETIRIZINE HYDROCHLORIDE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2Legacy NDC, 4 package rows20220825_69a63e8c-e225-4556-873e-9e5eb18c82f0.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.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.67207357-5f8a-4424-9901-d2717a43cf1b2026-07-14WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Rite Aid childrens allergy reliefCETIRIZINE HYDROCHLORIDERite Aid Corporationedbefbee-26b6-46bc-abcc-f7b2817705e52024-12-19WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Childrens AllergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Inc9a8b5af0-72bb-48d5-bb5e-0dc6808bf4662024-12-19WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
All Day AllergyCETIRIZINE HYDROCHLORIDEAmerisource Bergen6ce39876-47bf-4147-885d-4eb0aeb66fd02020-06-18WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Wal-Zyr All Day AllergyCETIRIZINE HYDROCHLORIDEWALGREEN COMPANY4ce79791-748a-49d0-af34-73f589670d3f2019-02-07WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Allergy ReliefCETIRIZINE HYDROCHLORIDEH E Bfdd3f9a0-b4be-498a-b8e0-1a97403997362018-05-09WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Inc0d026538-5708-4030-b65d-18790e72059a2018-02-14WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546
Childrens CetirzineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLC6b22f568-7ebd-4479-b764-6e5481d8c15a2017-06-12WarningsExact identifier
application applno (ANDA): 201546
application number: ANDA201546

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine HCl 1 MG/ML Oral SyrupSY69a63e8c-e225-4556-873e-9e5eb18c82f02
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY69a63e8c-e225-4556-873e-9e5eb18c82f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2148-1516722148011 BOTTLE in 1 CARTON (51672-2148-1) > 240 mL in 1 BOTTLE1 bottle2022-06-290000-00-00NoNoCurrent
51672-2148-8516722148081 BOTTLE in 1 CARTON (51672-2148-8) > 120 mL in 1 BOTTLE1 bottle2022-06-290000-00-00NoNoCurrent