FDA.reportPublic FDA data

Good Sense

Product NDC
50804-092
11-digit product format
508040092
Labeler code
50804
Product ID
50804-092_b46093d4-340a-444a-a9ad-d3e8022f8eb8
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Geiss, Destin & Dunn, 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
50804-092-082020-01-31C16284748780-19d75b9d0-9e1d-f424-e053-dadaa90a57ceGood Sense ® Children's Loratadine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-092-08Good Sense Childrens Loratadine1 in 1 CARTONSOLUTION12
50804-092-08Good Sense Childrens Loratadine120 mL in 1 BOTTLESOLUTION1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QNGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
LoratadineACTIVE MOIETY7AJO3BO7QNGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
phosphoric acidINACTIVE INGREDIENTE4GA8884NNGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956GOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
sorbitolINACTIVE INGREDIENT506T60A25RGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RGOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-092GOOD SENSE CHILDRENS LORATADINE (LORATADINE) SOLUTION [GEISS, DESTIN & DUNN, INC.]2Legacy NDC, 2 package rows20150424_1cd1d710-0c4d-49ef-8b7d-daac8597b2a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN1cd1d710-0c4d-49ef-8b7d-daac8597b2a92
692783loratadine 1 MG/ML Oral SolutionSCD1cd1d710-0c4d-49ef-8b7d-daac8597b2a92
692783loratadine 5 MG per 5 ML Oral SolutionSY1cd1d710-0c4d-49ef-8b7d-daac8597b2a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50804-092-08508040092081 in 1 CARTONHistorical