FDA.reportPublic FDA data

Allergy Relief

Product NDC
46122-531
11-digit product format
461220531
Labeler code
46122
Product ID
46122-531_7dc5bf93-f17c-3267-33d9-f123f53c072b
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-04-20
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 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
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-531-05Allergy Relief35 in 1 BOTTLETABLET, COATED3510
46122-531-05Allergy Relief1 in 1 CARTONTABLET, COATED110
46122-531-52Allergy Relief2 in 1 CARTONTABLET, COATED210
46122-531-52Allergy Relief5 in 1 BLISTER PACKTABLET, COATED510
46122-531-61Allergy Relief1 in 1 CARTONTABLET, COATED110
46122-531-61Allergy Relief80 in 1 BOTTLETABLET, COATED8010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-531-05EA - Each46122-53122ee253e-c222-4076-86ad-6d00078a655f12020-05-08
46122-531-52EA - Each46122-53187fe1a2c-90c1-41af-b2ba-0c9e1bace5cd12021-03-02
46122-531-61EA - Each46122-531a32d1ed3-90ed-4be7-899d-ecc661442d1612025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-531ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, COATED [AMERISOURCEBERGEN DRUG CORPORATION]8Current NDC, Legacy NDC, 6 package rows20250521_fdf54de3-16a9-3b28-b4c4-d745322b3d3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNfdf54de3-16a9-3b28-b4c4-d745322b3d3c10
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDfdf54de3-16a9-3b28-b4c4-d745322b3d3c10
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYfdf54de3-16a9-3b28-b4c4-d745322b3d3c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-531-05461220531051 BOTTLE in 1 CARTON (46122-531-05) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-04-200000-00-00NoNoCurrent
46122-531-52461220531522 BLISTER PACK in 1 CARTON (46122-531-52) > 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-07-060000-00-00NoNoCurrent
46122-531-61461220531611 BOTTLE in 1 CARTON (46122-531-61) / 80 TABLET, COATED in 1 BOTTLE1 bottle2023-09-01NoNoHistorical