FDA.reportPublic FDA data

All Day Allergy Relief

Product NDC
55910-039
11-digit product format
559100039
Labeler code
55910
Product ID
55910-039_41bbe91b-7c66-4998-89ab-263654c4fb6d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA077946
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
2027-01-31
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
All Day Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-039-452020-12-03C16284748780-1ab0e2407-26f0-f274-e053-dbdaa90a6471Cetirizine Hydrochloride Tablets
55910-039-452020-09-27C16284748780-1ab0e2407-26f0-f274-e053-dbdaa90a6471Cetirizine Hydrochloride Tablets
55910-039-452020-09-25C16284748780-1ab0e2407-26f0-f274-e053-dbdaa90a6471Cetirizine Hydrochloride Tablets
55910-039-452020-07-22C16284748780-1ab0e2407-26f0-f274-e053-dbdaa90a6471Cetirizine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-039-45All Day Allergy Relief1 in 1 BOXTABLET14
55910-039-45All Day Allergy Relief45 in 1 BOTTLE, PLASTICTABLET454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-039ALL DAY ALLERGY RELIEF (CETIRIZINE HCL) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Current NDC, Legacy NDC, 2 package rows20221108_76ec3257-9206-4a0f-a2cf-8a05217b92e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN76ec3257-9206-4a0f-a2cf-8a05217b92e74
1014678cetirizine hydrochloride 10 MG Oral TabletSCD76ec3257-9206-4a0f-a2cf-8a05217b92e74
1014678cetirizine HCl 10 MG Oral TabletSY76ec3257-9206-4a0f-a2cf-8a05217b92e74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-039-45559100039451 BOTTLE, PLASTIC in 1 BOX (55910-039-45) / 45 TABLET in 1 BOTTLE, PLASTIC2019-07-012027-01-31NoNoCurrent