Allergy Relief

Product NDC
53943-116
11-digit product format
539430116
Labeler code
53943
Product ID
53943-116_f1107c48-3f24-841d-e053-2995a90a6e68
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DISCOUNT DRUG MART, INC.
Application
ANDA202538
Marketing category
ANDA
Marketing start
2021-08-20
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-116-132025-01-30C16284748780-12cef2736-82e7-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-116-13Allergy Relief30 in 1 BOTTLECAPSULE, LIQUID FILLED302
53943-116-13Allergy Relief1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-116ALLERGY RELIEF (LORATADINE) CAPSULE, LIQUID FILLED [DISCOUNT DRUG MART, INC.]2Legacy NDC, 2 package rows20221231_c9fbadd0-d623-3c1f-e053-2995a90a6247.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSNc9fbadd0-d623-3c1f-e053-2995a90a62472
828269loratadine 10 MG Oral CapsuleSCDc9fbadd0-d623-3c1f-e053-2995a90a62472
828269loratadine 10 MG 24HR Oral CapsuleSYc9fbadd0-d623-3c1f-e053-2995a90a62472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-116-13539430116131 BOTTLE in 1 CARTON (53943-116-13) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-08-200000-00-00NoNoCurrent