FDA.reportPublic FDA data

All Day

Product NDC
46122-101
11-digit product format
461220101
Labeler code
46122
Product ID
46122-101_659426e2-438c-40c1-8bb6-bb036168f8b6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA201546
Marketing category
ANDA
Marketing start
2011-05-20
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-101-262020-06-22C16284748780-19d75b9cf-f188-f424-e053-dadaa90a57ceAll Day Allergy
46122-101-262020-01-31C16284748780-19d75b9cf-f188-f424-e053-dadaa90a57ceAll Day Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-101-26All Day Allergy1 in 1 CARTONSOLUTION13
46122-101-26All Day Allergy118 mL in 1 BOTTLESOLUTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-101ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20200623_6ce39876-47bf-4147-885d-4eb0aeb66fd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN6ce39876-47bf-4147-885d-4eb0aeb66fd03
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD6ce39876-47bf-4147-885d-4eb0aeb66fd03
1014673cetirizine HCl 1 MG/ML Oral SyrupSY6ce39876-47bf-4147-885d-4eb0aeb66fd03
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY6ce39876-47bf-4147-885d-4eb0aeb66fd03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-101-26461220101261 BOTTLE in 1 CARTON (46122-101-26) / 118 mL in 1 BOTTLE1 bottle2011-05-200000-00-00NoNoCurrent