FDA.reportPublic FDA data

SIMPLY RIGHT

Product NDC
68196-102
11-digit product format
681960102
Labeler code
68196
Product ID
68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA090182
Marketing category
ANDA
Marketing start
2011-09-08
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/5mL
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
SIMPLY RIGHT
Brand name suffix
childrens cetirizine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-102-01SIMPLY RIGHTchildrens cetirizine2 in 1 CARTONSOLUTION25
68196-102-01SIMPLY RIGHTchildrens cetirizine240 mL in 1 BOTTLESOLUTION2405
68196-102-02SIMPLY RIGHTchildrens cetirizine120 mL in 1 BOTTLESOLUTION1205
68196-102-02SIMPLY RIGHTchildrens cetirizine2 in 1 CARTONSOLUTION25
68196-102-07SIMPLY RIGHTchildrens cetirizine240 mL in 1 BOTTLESOLUTION2405
68196-102-07SIMPLY RIGHTchildrens cetirizine2 in 1 CARTONSOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-102SIMPLY RIGHT CHILDRENS CETIRIZINE (CETIRIZINE HYDROCHLORIDE) SOLUTION [SAM'S WEST INC]5Current NDC, Legacy NDC, 6 package rows20240625_48b47541-cf0c-48a7-9a65-2158fd1284f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN48b47541-cf0c-48a7-9a65-2158fd1284f15
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD48b47541-cf0c-48a7-9a65-2158fd1284f15
1014673cetirizine HCl 1 MG/ML Oral SyrupSY48b47541-cf0c-48a7-9a65-2158fd1284f15
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY48b47541-cf0c-48a7-9a65-2158fd1284f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-102-01681960102012 BOTTLE in 1 CARTON (68196-102-01) > 240 mL in 1 BOTTLE2 bottle2011-09-080000-00-00NoNoCurrent
68196-102-02681960102022 BOTTLE in 1 CARTON (68196-102-02) / 120 mL in 1 BOTTLE2 bottle2011-09-080000-00-00NoNoCurrent
68196-102-07681960102072 BOTTLE in 1 CARTON (68196-102-07) / 240 mL in 1 BOTTLE2 bottle2011-09-080000-00-00NoNoCurrent