FDA.reportPublic FDA data

CounterAct

Product NDC
54473-166
11-digit product format
544730166
Labeler code
54473
Product ID
54473-166_308f1711-b64c-1708-e063-6294a90ad99b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Melaleuca, Inc.
Application
ANDA075209
Marketing category
ANDA
Marketing start
2023-08-19
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
54473-166-312025-03-17C16284748780-12cef2736-870d-d83d-e063-dadaa90ab31fCounterAct Allergy Content of Label
54473-166-312025-01-30C16284748780-12cef2736-870d-d83d-e063-dadaa90ab31fCounterAct Allergy Content of Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-166-32CounterActAllergy30 in 1 BOTTLETABLET304
54473-166-32CounterActAllergy1 in 1 BOXTABLET14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNCOUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNCOUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCOUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-166COUNTERACT ALLERGY (LORATADINE) TABLET [MELALEUCA, INC.]4Current NDC, Legacy NDC, 2 package rows20250321_6b5d43ad-a709-4e0b-b91c-36ea0afe7221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN6b5d43ad-a709-4e0b-b91c-36ea0afe72214
311372loratadine 10 MG Oral TabletSCD6b5d43ad-a709-4e0b-b91c-36ea0afe72214
311372loratadine 10 MG 24 HR Oral TabletSY6b5d43ad-a709-4e0b-b91c-36ea0afe72214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-166-30544730166303 BLISTER PACK in 1 CARTON (54473-166-30) > 10 TABLET in 1 BLISTER PACK3 blister pack2018-01-010000-00-00NoNoCurrent
54473-166-32544730166321 BOTTLE in 1 BOX (54473-166-32) / 30 TABLET in 1 BOTTLE1 bottle2025-02-28NoNoCurrent