Childrens All Day Allergy

Product NDC
42507-203
11-digit product format
425070203
Labeler code
42507
Product ID
42507-203_8535c58e-263d-444f-b925-a5ede8b06e85
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
HyVee Inc
Application
ANDA204226
Marketing category
ANDA
Marketing start
2014-02-17
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 24 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 packagepackage42507-203-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42507-203-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42507-203-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42507-203-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42507-203-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42507-203-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42507-203-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42507-203-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42507-203-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42507-203-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42507-203-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42507-203-26557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens All Day Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014673Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
178743fd-5336-4aae-9a0a-5ff17aeb3762Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-203-00Childrens All Day Allergy118 mL in 1 BOTTLESOLUTION1184
42507-203-26Childrens All Day Allergy1 in 1 CARTONSOLUTION14

DailyMed Socrata Ingredients#

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
TopCare Childrens All Day AllergyCETIRIZINE HCLTopco Associates LLC48555c1f-8c2a-4ab2-9af3-d2488ca509e42025-04-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company5cdd59a0-4d23-4f51-9aca-d66a639f84722025-04-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Childrens All Day AllergyCETIRIZINE HCLKroger Company9526b509-40fb-4bab-b7b5-13ab600b728a2025-04-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
basic care childrens all day allergyCETIRIZINE HCLAmazon.com Services LLCe32a86d9-e992-4212-b503-dcda524672a22025-04-29WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company2a62f905-663f-4aae-991f-a368b5120f6f2025-04-24WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Good Sense Childrens All Day AllergyCETIRIZINE HCLL. Perrigo Company19120ef7-e9ca-435d-beab-6278b5756d6b2025-03-14WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Dye Free Childrens Cetirizine HydrocholrideCETIRIZINE HCLPrecision Dose, Inc.6a7c4dff-66c6-4d0c-af10-d908c65a43be2025-02-12WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Good Sense Childrens All Day AllergyCETIRIZINE HCLPreferred Pharmaceuticals Inc.0be90b3d-be71-4d38-bbf7-bf89a647ca8e2025-01-20WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Good Neighbor Pharmacy Childrens All Day AllergyCETIRIZINE HCLAmerisource Bergenc6951587-fe03-4bc8-8f0c-0687d49f71592025-01-03WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Members Mark Childrens CetirizineCETIRIZINE HYDROCHLORIDESam's West Inc9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d2024-09-25WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens allergy reliefCETIRIZINE HYDROCHLORIDESafeway5d3e4c52-b697-4b91-af28-124f74d937e52024-08-02WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
up and up childrens allergyCETIRIZINE HYDROCHLORIDETarget Corporation4b1ee9b1-d22e-4fb2-8dcd-912374da12d72024-06-06WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
up and up childrens allergyCETIRIZINE HYDROCHLORIDETarget Corporation1f37c327-cd4c-4bc1-ae70-713569694e2e2024-06-04WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens allergy reliefCETIRIZINE HYDROCHLORIDESafewaycfc3daa5-7248-4105-95ee-4e19199655ce2024-04-30WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
foster and thrive childrens allergy reliefCETIRIZINE HCLStrategic Sourcing Services LLCdc201cee-dbc3-4f28-babe-8e48ab79f4ab2023-09-20WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Kirkland Signature Childrens Aller TecCETIRIZINE HCLCostco Wholesale Companyeb14a311-7918-4c4b-ae05-7606cfb8a4af2023-05-04WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
childrens cetirizine hydrochlorideCETIRIZINE HCLProficient Rx LP8ef674ef-82a3-4a2b-8e5e-f8ca2ecccb1e2022-11-01WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226
Welby Childrens Allergy ReliefCETIRIZINE HYDROCHLORIDEAldi Inca8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a2022-10-13WarningsExact identifier
application applno (ANDA): 204226
application number: ANDA204226

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine HCl 1 MG/ML Oral SyrupSY178743fd-5336-4aae-9a0a-5ff17aeb37624
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY178743fd-5336-4aae-9a0a-5ff17aeb37624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-203-0042507020300118 mL in 1 BOTTLE118 mlHistorical
42507-203-26425070203261 BOTTLE in 1 CARTON (42507-203-26) / 118 mL in 1 BOTTLE (42507-203-00) 1 bottle2014-02-17NoNoCurrent