FDA.reportPublic FDA data

Loratadine Allergy Relief

Product NDC
50090-2387
11-digit product format
500902387
Labeler code
50090
Product ID
50090-2387_236a2808-6a6e-444d-a03c-b2a7ac90c255
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076134
Marketing category
ANDA
Marketing start
2017-11-01
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2387-02023-02-07C16284748780-1f386c649-e991-0266-e053-dadaa90a7c1aLoratadine Allergy Relief
50090-2387-02023-01-30C16284748780-1f386c649-e991-0266-e053-dadaa90a7c1aLoratadine Allergy Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2387-0Loratadine Allergy Relief30 in 1 BLISTER PACKTABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2387-0EA - Each50090-2387a6f29983-88e4-4cb5-a176-ca1002e960e112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2387LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240203_a53e5635-8633-4c28-b04f-cdfb3d851e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG Oral TabletSCDa53e5635-8633-4c28-b04f-cdfb3d851e6813
311372loratadine 10 MG 24 HR Oral TabletSYa53e5635-8633-4c28-b04f-cdfb3d851e6813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2387-05009023870030 TABLET in 1 BLISTER PACK (50090-2387-0) 30 tablet2017-11-010000-00-00NoNoCurrent