FDA.reportPublic FDA data

Allergy Relief

Product NDC
71335-9733
11-digit product format
713359733
Labeler code
71335
Product ID
71335-9733_31252a38-932c-43d2-852f-4d2d75fbf997
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

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
71335-9733-1Allergy Relief30 in 1 BOTTLE, PLASTICTABLET30104
71335-9733-2Allergy Relief14 in 1 BOTTLE, PLASTICTABLET14104
71335-9733-3Allergy Relief7 in 1 BOTTLE, PLASTICTABLET7104
71335-9733-4Allergy Relief10 in 1 BOTTLE, PLASTICTABLET10104
71335-9733-5Allergy Relief15 in 1 BOTTLE, PLASTICTABLET15104
71335-9733-6Allergy Relief90 in 1 BOTTLE, PLASTICTABLET90104
71335-9733-7Allergy Relief20 in 1 BOTTLE, PLASTICTABLET20104
71335-9733-8Allergy Relief60 in 1 BOTTLE, PLASTICTABLET60104
71335-9733-9Allergy Relief100 in 1 BOTTLE, PLASTICTABLET100104

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9733-17133597330130 TABLET in 1 BOTTLE, PLASTIC (71335-9733-1) 30 tablet2023-07-05NoNoHistorical
71335-9733-27133597330214 TABLET in 1 BOTTLE, PLASTIC (71335-9733-2) 14 tablet2023-06-27NoNoHistorical
71335-9733-3713359733037 TABLET in 1 BOTTLE, PLASTIC (71335-9733-3) 7 tablet2024-04-05NoNoHistorical
71335-9733-47133597330410 TABLET in 1 BOTTLE, PLASTIC (71335-9733-4) 10 tablet2024-04-05NoNoHistorical
71335-9733-57133597330515 TABLET in 1 BOTTLE, PLASTIC (71335-9733-5) 15 tablet2024-04-05NoNoHistorical
71335-9733-67133597330690 TABLET in 1 BOTTLE, PLASTIC (71335-9733-6) 90 tablet2024-04-05NoNoHistorical
71335-9733-77133597330720 TABLET in 1 BOTTLE, PLASTIC (71335-9733-7) 20 tablet2024-04-05NoNoHistorical
71335-9733-87133597330860 TABLET in 1 BOTTLE, PLASTIC (71335-9733-8) 60 tablet2024-04-05NoNoHistorical
71335-9733-971335973309100 TABLET in 1 BOTTLE, PLASTIC (71335-9733-9) 100 tablet2023-07-25NoNoHistorical