FDA.reportPublic FDA data

foster and thrive childrens allergy relief

Product NDC
70677-1042
11-digit product format
706771042
Labeler code
70677
Product ID
70677-1042_71e135cb-29cd-4858-92ed-05fb09688563
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA204226
Marketing category
ANDA
Marketing start
2023-09-20
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
foster and thrive childrens allergy relief
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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1042-1foster and thrive childrens allergy relief1 in 1 CARTONSOLUTION12
70677-1042-1foster and thrive childrens allergy relief120 mL in 1 BOTTLESOLUTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1042-1ML - Milliliter70677-1042d2ad16f9-8d67-4311-8441-33bf858bbd5512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1042FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF (CETIRIZINE HCL) SOLUTION [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20230922_dc201cee-dbc3-4f28-babe-8e48ab79f4ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNdc201cee-dbc3-4f28-babe-8e48ab79f4ab2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDdc201cee-dbc3-4f28-babe-8e48ab79f4ab2
1014673cetirizine HCl 1 MG/ML Oral SyrupSYdc201cee-dbc3-4f28-babe-8e48ab79f4ab2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYdc201cee-dbc3-4f28-babe-8e48ab79f4ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1042-1706771042011 BOTTLE in 1 CARTON (70677-1042-1) / 120 mL in 1 BOTTLE1 bottle2023-09-20NoNoHistorical