FDA.reportPublic FDA data

AU KAH CHUEN ANTIFUNGAL

Product NDC
72030-100
11-digit product format
720300100
Labeler code
72030
Product ID
72030-100_43e72fea-a3c2-9339-e063-6394a90a2097
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
LOTION
Route
TOPICAL
Labeler
ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-26
Marketing end
2029-08-30
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AU KAH CHUEN ANTIFUNGAL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui197531

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72030-100-012025-11-18C16284748780-1ba0f9c33-23ea-a910-e053-dadaa90a0b85Drug Facts
72030-100-012021-01-29C16284748780-1ba0f9c33-23ea-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72030-100-01AU KAH CHUEN ANTIFUNGAL1 in 1 BOXLOTION12
72030-100-01AU KAH CHUEN ANTIFUNGAL24 mL in 1 BOTTLE, WITH APPLICATORLOTION242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72030-100AU KAH CHUEN ANTIFUNGAL (CLOTRIMAZOLE) LOTION [ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.]1Current NDC, Legacy NDC, 2 package rows20181130_3a262bcd-e6c0-4554-ab1c-9c861f90e190.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197531clotrimazole 1 % Topical LotionPSN3a262bcd-e6c0-4554-ab1c-9c861f90e1902
197531clotrimazole 10 MG/ML Topical LotionSCD3a262bcd-e6c0-4554-ab1c-9c861f90e1902
197531clotrimazole 1 % Topical LotionSY3a262bcd-e6c0-4554-ab1c-9c861f90e1902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72030-100-01720300100011 BOTTLE, WITH APPLICATOR in 1 BOX (72030-100-01) / 24 mL in 1 BOTTLE, WITH APPLICATOR2018-11-262029-08-30NoNoHistorical