FDA.reportPublic FDA data

Au Kah Chuen Fugical

Product NDC
69070-306
11-digit product format
690700306
Labeler code
69070
Product ID
69070-306_4345b4b7-3e93-9d68-e063-6294a90a7d77
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Diphenhydramine hydrochlorid
Dosage form
CREAM
Route
TOPICAL
Labeler
Zhejiang Dingtai Pharmaceutical Co., Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-10
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; FERRIC OXIDE RED; ZINC OXIDE
Active strength
2; .05; 9.95 g/100g; g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Au Kah Chuen Fugical
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
FERRIC OXIDE RED.05 g/100g
ZINC OXIDE9.95 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, 1K09F3G675, SOI2LOH54Z
Rxcui2727332

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69070-306-01Au Kah Chuen Fugical1 in 1 BOXCREAM13
69070-306-01Au Kah Chuen Fugical15 g in 1 TUBECREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69070-306AU KAH CHUEN FUGICAL (CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID) CREAM [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD]2Current NDC, Legacy NDC, 2 package rows20241127_5b4add17-6c3d-4093-826a-2edb41c1d1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727332calamine 10 % / diphenhydrAMINE hydrochloride 2 % Topical CreamPSN5b4add17-6c3d-4093-826a-2edb41c1d1db3
2727332calamine 100 MG/ML / diphenhydramine hydrochloride 20 MG/ML Topical CreamSCD5b4add17-6c3d-4093-826a-2edb41c1d1db3
2727332calamine 10 % / diphenhydramine hydrochloride 2 % Topical CreamSY5b4add17-6c3d-4093-826a-2edb41c1d1db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69070-306-01690700306011 TUBE in 1 BOX (69070-306-01) / 15 g in 1 TUBE1 tube2019-06-100000-00-00NoNoCurrent