FDA.reportPublic FDA data

Allergy Relief

Product NDC
37808-564
11-digit product format
378080564
Labeler code
37808
Product ID
37808-564_dc1a3b00-493f-49ca-ad0a-7281eb9a726d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
H E B
Application
ANDA213105
Marketing category
ANDA
Marketing start
2021-10-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-564-25Allergy Relief25 in 1 BOTTLECAPSULE255
37808-564-25Allergy Relief1 in 1 BOXCAPSULE15
37808-564-40Allergy Relief1 in 1 BOXCAPSULE15
37808-564-40Allergy Relief40 in 1 BOTTLE, PLASTICCAPSULE405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-564ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE [H E B]5Current NDC, Legacy NDC, 4 package rows20240511_4bbf0be5-7bcc-46c6-a443-7b37d4679c6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN4bbf0be5-7bcc-46c6-a443-7b37d4679c6f5
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD4bbf0be5-7bcc-46c6-a443-7b37d4679c6f5
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY4bbf0be5-7bcc-46c6-a443-7b37d4679c6f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-564-25378080564251 BOTTLE in 1 BOX (37808-564-25) / 25 CAPSULE in 1 BOTTLE1 bottle2021-10-150000-00-00NoNoCurrent
37808-564-40378080564401 BOTTLE, PLASTIC in 1 BOX (37808-564-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC2021-10-15NoNoCurrent