FDA.reportPublic FDA data

Childrens Allergy

Product NDC
69842-337
11-digit product format
698420337
Labeler code
69842
Product ID
69842-337_e2e54d0e-d60a-4958-94f2-1a0daa0d2bc8
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075728
Marketing category
ANDA
Marketing start
2018-06-20
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-337-26Childrens Allergy1 in 1 CARTONSOLUTION13
69842-337-26Childrens Allergy120 mL in 1 BOTTLESOLUTION1203
69842-337-34Childrens Allergy1 in 1 CARTONSOLUTION13
69842-337-34Childrens Allergy240 mL in 1 BOTTLESOLUTION2403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-337-26ML - Milliliter69842-337794b0ed6-d540-481f-9bf0-5bbad860aff612022-09-12
69842-337-34ML - Milliliter69842-3375914e4fb-a159-4de3-ab30-cd767907804512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-337CHILDRENS ALLERGY (LORATADINE) SOLUTION [CVS PHARMACY]3Current NDC, Legacy NDC, 4 package rows20240816_13c40819-24af-48f1-8371-9e32dc5339a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN13c40819-24af-48f1-8371-9e32dc5339a13
692783loratadine 1 MG/ML Oral SolutionSCD13c40819-24af-48f1-8371-9e32dc5339a13
692783loratadine 5 MG per 5 ML Oral SolutionSY13c40819-24af-48f1-8371-9e32dc5339a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-337-26698420337261 BOTTLE in 1 CARTON (69842-337-26) / 120 mL in 1 BOTTLE1 bottle2018-06-280000-00-00NoNoCurrent
69842-337-34698420337341 BOTTLE in 1 CARTON (69842-337-34) / 240 mL in 1 BOTTLE1 bottle2018-06-200000-00-00NoNoCurrent