FDA.reportPublic FDA data

Allergy Relief

Product NDC
21130-712
11-digit product format
211300712
Labeler code
21130
Product ID
21130-712_38a06b8a-bd81-4696-e063-6294a90a1f38
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS, LLC
Application
ANDA078933
Marketing category
ANDA
Marketing start
2023-05-31
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
21130-712-03Allergy Relief1 in 1 CARTONTABLET16
21130-712-03Allergy Relief30 in 1 BOTTLETABLET306
21130-712-09Allergy Relief90 in 1 BOTTLETABLET906
21130-712-12Allergy Relief1 in 1 CARTONTABLET16
21130-712-12Allergy Relief120 in 1 BOTTLETABLET1206
21130-712-46Allergy Relief14 in 1 BLISTER PACKTABLET146
21130-712-46Allergy Relief1 in 1 CARTONTABLET16
21130-712-58Allergy Relief45 in 1 BOTTLETABLET456
21130-712-58Allergy Relief1 in 1 CARTONTABLET16
21130-712-81Allergy Relief2 in 1 CARTONTABLET26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-712ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [BETTER LIVING BRANDS, LLC]5Current NDC, 10 package rows20231003_eb60ae7d-87db-7413-e053-2a95a90afd76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNeb60ae7d-87db-7413-e053-2a95a90afd766
1014678cetirizine hydrochloride 10 MG Oral TabletSCDeb60ae7d-87db-7413-e053-2a95a90afd766
1014678cetirizine HCl 10 MG Oral TabletSYeb60ae7d-87db-7413-e053-2a95a90afd766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-712-03211300712031 BOTTLE in 1 CARTON (21130-712-03) / 30 TABLET in 1 BOTTLE1 bottle2023-05-31NoNoCurrent
21130-712-092113007120990 in 1 BOTTLEHistorical
21130-712-12211300712121 BOTTLE in 1 CARTON (21130-712-12) / 120 TABLET in 1 BOTTLE1 bottle2023-08-30NoNoCurrent
21130-712-46211300712461 BLISTER PACK in 1 CARTON (21130-712-46) / 14 TABLET in 1 BLISTER PACK1 blister pack2023-06-26NoNoCurrent
21130-712-58211300712581 BOTTLE in 1 CARTON (21130-712-58) / 45 TABLET in 1 BOTTLE1 bottle2023-05-31NoNoCurrent
21130-712-81211300712812 BOTTLE in 1 CARTON (21130-712-81) / 90 TABLET in 1 BOTTLE (21130-712-09) 2 bottle2023-06-23NoNoCurrent