Western Family

Product NDC
55312-092
11-digit product format
553120092
Labeler code
55312
Product ID
55312-092_56dbc128-2638-4e66-b01d-10394e177073
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Western Family Foods Inc
Application
ANDA076805
Marketing category
ANDA
Marketing start
2010-02-27
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-092-082020-01-31C16284748780-19d75b9d0-ffca-f424-e053-dadaa90a57ceWestern Family ® Children's Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-092-08Western Family Childrens Allergy Relief120 mL in 1 BOTTLESOLUTION1202
55312-092-08Western Family Childrens Allergy Relief1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
LoratadineACTIVE MOIETY7AJO3BO7QNWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
phosphoric acidINACTIVE INGREDIENTE4GA8884NNWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3WESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956WESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
sorbitolINACTIVE INGREDIENT506T60A25RWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2
waterINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-092WESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]2Legacy NDC, 2 package rows20140327_2ac0d97a-35a9-4656-a614-1c8c06a89650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN2ac0d97a-35a9-4656-a614-1c8c06a896502
692783loratadine 1 MG/ML Oral SolutionSCD2ac0d97a-35a9-4656-a614-1c8c06a896502
692783loratadine 5 MG per 5 ML Oral SolutionSY2ac0d97a-35a9-4656-a614-1c8c06a896502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-092-0855312009208120 mL in 1 BOTTLE120 mlHistorical