allergy relief

Product NDC
21130-425
11-digit product format
211300425
Labeler code
21130
Product ID
21130-425_8b6eebd5-99d8-4acf-aec4-2b1c8d32ed4b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA078336
Marketing category
ANDA
Marketing start
2025-09-11
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
21130-425-95allergy relief1 in 1 CARTONTABLET, FILM COATED12
21130-425-95allergy relief45 in 1 BOTTLETABLET, FILM COATED452

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2
1014678cetirizine HCl 10 MG Oral TabletSYc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-425-95211300425951 BOTTLE in 1 CARTON (21130-425-95) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-09-11NoNoCurrent