Home NDC 69070-306 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 ZINC OXIDE; FERRIC OXIDE RED; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 9.95; .05; 2 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Au Kah Chuen Fugical
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.95 g/100g FERRIC OXIDE RED .05 g/100g DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 1K09F3G675 Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2727332 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69070-306-01 Au Kah Chuen Fugical 1 in 1 BOX CREAM 1 3 69070-306-01 Au Kah Chuen Fugical 15 g in 1 TUBE CREAM 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69070-306 AU KAH CHUEN FUGICAL (CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID) CREAM [ZHEJIANG DINGTAI PHARMACEUTICAL CO., LTD] 2 Current NDC, Legacy NDC, 2 package rows 20241127_5b4add17-6c3d-4093-826a-2edb41c1d1db.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 28 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69070-306-01 69070030601 1 TUBE in 1 BOX (69070-306-01) / 15 g in 1 TUBE 1 tube 2019-06-10 0000-00-00 No No Current