FDA.reportPublic FDA data

Allergy Relief

Product NDC
69230-304
11-digit product format
692300304
Labeler code
69230
Product ID
69230-304_b8be3856-df10-42ac-8700-3d1701b5642d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care
Application
ANDA209274
Marketing category
ANDA
Marketing start
2018-12-31
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

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
Rxcui1014678

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
69230-304-01Allergy Relief100 in 1 BOTTLE, PLASTICTABLET1009
69230-304-01Allergy Relief1 in 1 BOXTABLET19
69230-304-05Allergy Relief500 in 1 BOTTLETABLET5009
69230-304-30Allergy Relief30 in 1 BOTTLE, PLASTICTABLET309
69230-304-30Allergy Relief1 in 1 BOXTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-304-01EA - Each69230-304ca58f211-7aaf-4092-8207-a1b97f36e99912019-04-11
69230-304-05EA - Each69230-30429585938-535e-4bb3-9ae8-65be9c259d9012019-06-19
69230-304-30EA - Each69230-304b2189fc5-031f-431f-ae41-7ee22600fb7112019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-304ALLERGY RELIEF (CETIRIZINE HCL) TABLET [CAMBER CONSUMER CARE]9Current NDC, Legacy NDC, 5 package rows20250313_91cb9fe1-9c52-4c37-9751-3669207c6676.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea104
1014678cetirizine hydrochloride 10 MG Oral TabletSCD7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea104
1014678cetirizine HCl 10 MG Oral TabletSY7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea104
1014678cetirizine HCl 10 MG Oral TabletPSN91cb9fe1-9c52-4c37-9751-3669207c66769
1014678cetirizine hydrochloride 10 MG Oral TabletSCD91cb9fe1-9c52-4c37-9751-3669207c66769
1014678cetirizine HCl 10 MG Oral TabletSY91cb9fe1-9c52-4c37-9751-3669207c66769

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-304-01692300304011 BOTTLE, PLASTIC in 1 BOX (69230-304-01) / 100 TABLET in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent
69230-304-0569230030405500 TABLET in 1 BOTTLE (69230-304-05) 500 tablet2019-01-210000-00-00NoNoCurrent
69230-304-30692300304301 BOTTLE, PLASTIC in 1 BOX (69230-304-30) / 30 TABLET in 1 BOTTLE, PLASTIC2018-12-310000-00-00NoNoCurrent