Equaline childrens all day allergy

Product NDC
41163-475
11-digit product format
411630475
Labeler code
41163
Product ID
41163-475_c99843ad-3ee8-4fc0-843d-75ed4d53eebe
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA204226
Marketing category
ANDA
Marketing start
2015-11-17
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
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-47541163-475-34DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
Equaline childrens all day allergy
Listing expiration
2026-12-31

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
edd4240d-f719-4336-88fe-0960cd8006e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-475-26Equaline childrens all day allergy1 in 1 CARTONSOLUTION15
41163-475-26Equaline childrens all day allergy118 mL in 1 BOTTLESOLUTION1185
41163-475-34Equaline childrens all day allergy1 in 1 CARTONSOLUTION15
41163-475-34Equaline childrens all day allergy240 mL in 1 BOTTLESOLUTION2405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-475-26ML - Milliliter41163-475c5ab9b0e-9d8a-4b35-a6d8-d9375a809a1312017-03-06
41163-475-34ML - Milliliter41163-475c52af8fe-ef26-4a0e-b22e-b9f2bd9e0b3512017-08-11

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-475EQUALINE CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI]5Current NDC, Legacy NDC, 4 package rows20250501_edd4240d-f719-4336-88fe-0960cd8006e0.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 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
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
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 SolutionPSNedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine HCl 1 MG/ML Oral SyrupSYedd4240d-f719-4336-88fe-0960cd8006e05
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYedd4240d-f719-4336-88fe-0960cd8006e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-475-26411630475261 BOTTLE in 1 CARTON (41163-475-26) / 118 mL in 1 BOTTLE1 bottle2015-11-170000-00-00NoNoCurrent
41163-475-34411630475341 BOTTLE in 1 CARTON (41163-475-34) > 240 mL in 1 BOTTLE1 bottle2016-01-070000-00-00NoNoCurrent