FDA.reportPublic FDA data

All Day Allergy

Product NDC
41520-212
11-digit product format
415200212
Labeler code
41520
Product ID
41520-212_67a5a75a-7a28-4d07-99b4-8325d1776f3a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Care One (American Sales Company)
Application
ANDA205291
Marketing category
ANDA
Marketing start
2024-12-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205291-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2017-07-21

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day AllergyCETIRIZINE HCLCare One (American Sales Company)01d0729f-11ef-4ec5-8d8e-2863407c3f952025-04-07WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warning

Additional Listing Data#

Finished product
Yes
Brand name base
All Day Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-212-25All Day Allergy1 in 1 BOXCAPSULE, LIQUID FILLED12
41520-212-25All Day Allergy25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-212ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]2Current NDC, 2 package rows20250409_01d0729f-11ef-4ec5-8d8e-2863407c3f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN01d0729f-11ef-4ec5-8d8e-2863407c3f952
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD01d0729f-11ef-4ec5-8d8e-2863407c3f952
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY01d0729f-11ef-4ec5-8d8e-2863407c3f952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
41520-212-25415200212251 BOTTLE, PLASTIC in 1 BOX (41520-212-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2024-12-31NoNoCurrent