Application 204226

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2013-09-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09cb3db0bc1861…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLCf9b17231-1787-4726-8e19-cf3430dd811c2026-07-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens allergy reliefCETIRIZINE HCLRite Aid Corporation978d8779-3c00-4b21-9cc3-f6a962194dfe2026-07-24WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 11822-1189
childrens allergy reliefCETIRIZINE HCLRite Aid Corporation09474431-cf46-45da-8b20-9551ddea28a72026-07-24WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 11822-0475
childrens dye free allergy reliefCETIRIZINE HCLKroger Company2ecf7dac-97fd-49b3-87ce-9b473834bd7e2026-05-01WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-05-01WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens dye free allergy reliefCETIRIZINE HCLKroger Companyc6660c5c-1504-4a92-95e8-cc3a018e813b2026-04-30WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Good Sense Childrens All Day AllergyCETIRIZINE HCLL. Perrigo Companye56edd0e-4873-41bc-a727-05c02ec943ed2026-04-20WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 0113-0503
careone childrens allergy reliefCETIRIZINE HCLAmerican Sales Companya4e43301-3e03-4364-b303-645de16975722026-04-07WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 41520-301
childrens cetirizine hydrochlorideCETIRIZINE HCLPreferred Pharmaceuticals Inc.9e168299-5ba1-451a-8c85-3fbe34c36cb02026-03-25WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 68788-8188
Good Sense Childrens All Day AllergyCETIRIZINE HCLPreferred Pharmaceuticals Inc.8cf4615b-47f8-4b92-b0cd-16c380ad23202026-03-17WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Good Sense Childrens All Day AllergyCETIRIZINE HCLA-S Medication Solutions8c99c767-6b46-4819-89df-c02f478a45be2026-03-04WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens cetirizine hydrochlorideCETIRIZINE HCLMajor Pharmaceuticalsdb297aa4-4384-48f2-b2bd-c842efc8a8442026-02-13WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 0904-6765
Childrens All Day AllergyCETIRIZINE HCLHyVee Inc178743fd-5336-4aae-9a0a-5ff17aeb37622026-01-27WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 42507-203
childrens all day allergyCETIRIZINE HCLHyVee Inc2643640e-d144-41ae-919f-37be23e547aa2026-01-27WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 42507-475
Childrens 24 Hour AllergyCETIRIZINE HCLMeijer Distribution Inc4fba7f23-8123-4704-97a9-2c5d1e7e289a2025-07-30WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 41250-189
Childrens 24 Hour AllergyCETIRIZINE HCLMeijer Distribution Inc6a5549b3-e0a9-40e1-b80d-b81b2f1932c92025-06-25WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 41250-475
careone childrens allergy reliefCETIRIZINE HCLAmerican Sales Company0582736b-e129-4048-967c-6270c776f9db2025-06-12WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 41520-902
Leader Childrens all day allergyCETIRIZINE HCLCardinal Health 110, LLC. dba Leader6e69ba49-a487-445b-b5f3-5e468d86ac442025-04-30WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Equaline childrens all day allergyCETIRIZINE HCLUnited Natural Foods, Inc. dba UNFIedd4240d-f719-4336-88fe-0960cd8006e02025-04-30WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 41163-475
TopCare Childrens All Day AllergyCETIRIZINE HCLTopco Associates LLC48555c1f-8c2a-4ab2-9af3-d2488ca509e42025-04-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
ndc (product): 36800-475

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 94 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0189Good Sense Childrens All Day AllergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-0189Good Sense Childrens All Day AllergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-0503Good Sense Childrens All Day AllergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-7189basic care childrens all day allergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-7189basic care childrens all day allergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-7475basic care childrens all day allergyCetirizine HClL. Perrigo CompanyANDACurrent
0113-7475basic care childrens all day allergyCetirizine HClL. Perrigo CompanyANDACurrent
0363-0475childrens wal zyrCetirizine HClWalgreen CompanyANDACurrent
0363-0475childrens wal zyrCetirizine HClWalgreen CompanyANDACurrent
0363-0545Wal ZyrCetirizine HClWalgreen CompanyANDACurrent
0363-0545Wal ZyrCetirizine HClWalgreen CompanyANDACurrent
0363-0953Childrens Dye Free Wal ZyrCetirizine HClWalgreen CompanyANDACurrent
0363-0953Childrens Dye Free Wal ZyrCetirizine HClWalgreen CompanyANDACurrent
0363-1475childrens dye free wal zyrCetirizine HClWalgreen CompanyANDACurrent
0363-3311childrens allergy reliefCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-3393childrens allergy reliefCetirizine HydrochlorideWalgreen CompanyANDACurrent
0904-6765childrens cetirizine hydrochlorideCetirizine HClMajor PharmaceuticalsANDACurrent
0904-6765childrens cetirizine hydrochlorideCetirizine HClMajor PharmaceuticalsANDACurrent
11673-303up and up childrens allergy reliefCetirizine HClTarget CorporationANDACurrent
11673-303up and up childrens allergy reliefCetirizine HClTarget CorporationANDACurrent
11673-303up and up childrens allergy reliefCetirizine HClTarget CorporationANDACurrent
11673-475Up and Up Childrens Allergy ReliefCetirizine HClTarget CorporationANDACurrent
11822-0475childrens allergy reliefCetirizine HClRite Aid CorporationANDACurrent
11822-0475childrens allergy reliefCetirizine HClRite Aid CorporationANDACurrent
11822-0475childrens allergy reliefCetirizine HClRite Aid CorporationANDACurrent
11822-1189childrens allergy reliefCetirizine HClRite Aid CorporationANDACurrent
21130-189Signature Care Childrens Allergy ReliefCetirizine HClSafewayANDACurrent
21130-475Signature Care Childrens Allergy ReliefCetirizine HClSafewayANDACurrent
30142-189childrens all day allergyCetirizine HClKroger CompanyANDACurrent
30142-189childrens all day allergyCetirizine HClKroger CompanyANDACurrent
30142-475Childrens All Day AllergyCetirizine HClKroger CompanyANDACurrent
30142-475Childrens All Day AllergyCetirizine HClKroger CompanyANDACurrent
36800-189Topcare Childrens All Day AllergyCetirizine HClTopco Associates LLCANDACurrent
36800-189Topcare Childrens All Day AllergyCetirizine HClTopco Associates LLCANDACurrent
36800-475TopCare Childrens All Day AllergyCetirizine HClTopco Associates LLCANDACurrent
36800-475TopCare Childrens All Day AllergyCetirizine HClTopco Associates LLCANDACurrent
37012-475Childrens Allergy ReliefCetirizine HClShopko Stores Operating Co., LLCANDACurrent
41163-475Equaline childrens all day allergyCetirizine HClSupervalu IncANDACurrent
41190-475ShopRite Childrens AllergyCetirizine HClWakefern Food CorporationANDACurrent
41250-189Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-189Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-189Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-475Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-475Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-475Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-475Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41250-475Childrens 24 Hour AllergyCetirizine HClMeijer Distribution IncANDACurrent
41520-301careone childrens allergy reliefCetirizine HClAmerican Sales CompanyANDACurrent
41520-301careone childrens allergy reliefCetirizine HClAmerican Sales CompanyANDACurrent
41520-902careone childrens allergy reliefCetirizine HClAmerican Sales CompanyANDACurrent
42507-203Childrens All Day AllergyCetirizine HClHyVee IncANDACurrent
42507-475childrens all day allergyCetirizine HClHyVee IncANDACurrent
46122-203Good Neighbor Pharmacy Childrens All Day AllergyCetirizine HClAmerisource BergenANDACurrent
49738-031Smart Sense Allergy ReliefCetirizine HClKmart CorporationANDACurrent
49738-189Smart Sense Childrens AllergyCetirizine HClKmart CorporationANDACurrent
49738-475smart sense allergy reliefCetirizine HClKmart CorporationANDACurrent
55312-475AllergyCetirizine HClWestern Family Foods IncANDACurrent
55316-475Healthy Accents Childrens AllergyCetirizine HClDZA Brands LLCANDACurrent
55319-475Family Wellness childrens All Day AllergyCetirizine HClFamily Dollar Services IncANDACurrent
55319-901family wellness childrens allergyCetirizine HydrochlorideFamily Dollar Services IncANDACurrent
55910-475rexall all day allergy reliefCetirizine HClDolgencorp, LLCANDACurrent
55910-714DG Health Childrens All Day AllergyCetirizine HClDolgencorp, LLCANDACurrent
55910-714DG Health Childrens All Day AllergyCetirizine HClDolgencorp, LLCANDACurrent
55910-714DG Health Childrens All Day AllergyCetirizine HClDolgencorp, LLCANDACurrent
56062-475childrens allergyCetirizine HClPublix Super Markets IncANDACurrent
59779-509Childrens Allergy ReliefCetirizine HClCVS PharmacyANDACurrent
59779-837allergy reliefCetirizine HClCVS PharmacyANDACurrent
59779-837allergy reliefCetirizine HClCVS PharmacyANDACurrent
62011-0322Health Mart childrens all day allergyCetirizine HClMckessonANDACurrent
62011-0322Health Mart childrens all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0322Health Mart childrens all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0323Health Mart Childrens all day allergyCetirizine HClMckessonANDACurrent
62011-0323Health Mart Childrens all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
62011-0323Health Mart Childrens all day allergyCetirizine HClStrategic Sourcing Services LLCANDACurrent
63981-475Kirkland Signature Childrens Aller TecCetirizine HClCostco Wholesale CompanyANDACurrent
64024-475Welby Childrens Allergy ReliefCetirizine HydrochlorideAldi IncANDACurrent
68094-004Dye Free Childrens Cetirizine HydrocholrideCetirizine HydrochloridePrecision Dose, Inc.ANDACurrent
68788-8188childrens cetirizine hydrochlorideCetirizine HClPreferred Pharmaceuticals Inc.ANDACurrent
69256-475Harris Teeter Childrens All Day AllergyCetirizine HClHarris Teeter, LLCANDACurrent
70000-0214Leader Childrens All Day AllergyCetirizine HClCardinal HealthANDACurrent