FDA.reportPublic FDA data

Application 090182

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22
A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2008-04-22

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.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22e64feba35796…
2022-09-29 23:25 UTC2022-09A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSYRUP / ORAL2008-04-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2008-04-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090182-001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLSOLUTION / ORAL2008-04-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090182-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2008-04-22a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb73950f4-af6f-4dc7-bce2-9ec43c45eee52026-06-12WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 49035-276
HEB Allergy ReliefCETIRIZINE HYDROCHLORIDEH E B9abdae64-4c3d-47f3-8224-fc81f7bfe5572026-05-31WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 37808-102
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEVERITYRX, LLC42a1168e-e2cd-a1e5-e063-6294a90ab3b62025-11-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
childrens allergyCETIRIZINE HYDROCHLORIDEPublix Super Markets Incae216d0b-8ccc-4cc4-82f4-4d0f3a2568222025-07-15WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 56062-102
Premier Value Childrens CetirizineCETIRIZINE HYDROCHLORIDEPharmacy Value Alliance LLCa4931f0b-86f2-42c5-b2df-b359bb46f44a2025-07-11WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 68016-165
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC601c2846-30e7-40f1-96b4-64fbed719c0b2025-07-10WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.54d72d7a-1f5b-4b36-bf76-ab7aef6243ab2025-07-02WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 51672-2102
SIMPLY RIGHT childrens cetirizineCETIRIZINE HYDROCHLORIDESam's West Inc48b47541-cf0c-48a7-9a65-2158fd1284f12024-06-24WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 68196-102
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEProficient Rx LP582db483-394e-4c00-8522-4041a11696e42022-10-01WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 71205-705
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC (Premier Value)b47b0c8b-59d5-4e17-95be-a992c6861ee72019-01-23WarningsExact identifier
application applno (ANDA): 090182
application number: ANDA090182
ndc (product): 68016-023

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-2088Wal-ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-2102Wal-ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-2102Wal-ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
11673-102Target Childrens All Day Allergy ReliefCetirizine HydrochlorideTarget CorporationANDACurrent
11673-208Childrens All Day Allergy ReliefCetirizine HydrochlorideTarget CorporationANDACurrent
11822-0279Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-2102Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-2102Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-2102Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
30142-102ChildrensCetirizine HydrochlorideKroger CompanyANDACurrent
37808-102HEBCetirizine HydrochlorideH E BANDACurrent
37808-208H-E-BCetirizine HydrochlorideH E BANDACurrent
41250-102ChildrensCetirizine HydrochlorideMeijer Distribution IncANDACurrent
49035-088Childrens Allergy ReliefCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49035-276EquateCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49035-276EquateCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49348-326sunmarkCetirizine HydrochlorideMcKessonANDACurrent
49348-972ChildrensCetirizine HydrochlorideMcKessonANDACurrent
51672-2088Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2088Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2102Childrens Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2102Childrens Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2102Childrens Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
52183-088Cetirizine HydrochlorideCetirizine HydrochlorideBlacksmith Brands Inc.ANDACurrent
55319-104Childrens All Day AllergyCetirizine HydrochlorideFAMILY WELLNESSANDACurrent
55319-104Childrens All Day AllergyCetirizine HydrochlorideFAMILY WELLNESSANDACurrent
56062-102childrens allergyCetirizine HydrochloridePublix Super Markets IncANDACurrent
56062-102childrens allergyCetirizine HydrochloridePublix Super Markets IncANDACurrent
59779-276CVS PharmacyCetirizine HydrochlorideCVS PharmacyANDACurrent
61715-157Childrens Allergy ReliefCetirizine HydrochloridePreferred Plus (Kinray)ANDACurrent
62011-0051Health Mart Pharmacy Childrens Cetirizine HydrochlorideCetirizine hydrochlorideHealth MartANDACurrent
62011-0180HealthMartCetirizine HydrochlorideMcKessonANDACurrent
63868-093Quality Choice Childrens Allergy ReliefCetirizine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
63868-133Quality ChoiceCetirizine HydrochlorideChain Drug Marketing AssociationANDACurrent
63941-088Best ChoiceCetirizine HydrochlorideValu Merchandisers CompanyANDACurrent
63941-102Best ChoiceCetirizine HydrochlorideValu Merchandisers CompanyANDACurrent
68016-023Childrens Cetirizine HydrochlorideCetirizine HydrochlorideChain Drug Consortium, LLC (Premier Value)ANDACurrent
68016-165Premier ValueCetirizine HydrochloridePharmacy Value Alliance LLCANDACurrent
68071-4433Childrens Cetirizine HydrochlorideCetirizine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68196-102SIMPLY RIGHTCetirizine HydrochlorideSam's West IncANDACurrent
68196-102SIMPLY RIGHTCetirizine HydrochlorideSam's West IncANDACurrent
68196-102SIMPLY RIGHTCetirizine HydrochlorideSam's West IncANDACurrent
68196-102SIMPLY RIGHTCetirizine HydrochlorideSam's West IncANDACurrent
68788-8992Childrens Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8992Childrens Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8992Childrens Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9734Cetirizine HydrochlorideCetirizine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
71205-705Childrens Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent