au kah chuen fugical

Generic: calamine and diphenhydramine hydrochlorid

Labeler: zhejiang dingtai pharmaceutical co., ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name au kah chuen fugical
Generic Name calamine and diphenhydramine hydrochlorid
Labeler zhejiang dingtai pharmaceutical co., ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

diphenhydramine hydrochloride 2 g/100g, ferric oxide red .05 g/100g, zinc oxide 9.95 g/100g

Manufacturer
Zhejiang Dingtai Pharmaceutical Co., Ltd

Identifiers & Regulatory

Product NDC 69070-306
Product ID 69070-306_4345b4b7-3e93-9d68-e063-6294a90a7d77
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-06-10

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69070306
Hyphenated Format 69070-306

Supplemental Identifiers

RxCUI
2727332
UNII
TC2D6JAD40 1K09F3G675 SOI2LOH54Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name au kah chuen fugical (source: ndc)
Generic Name calamine and diphenhydramine hydrochlorid (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
  • .05 g/100g
  • 9.95 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69070-306-01) / 15 g in 1 TUBE
source: ndc

Packages (1)

69070-306-01 1 TUBE in 1 BOX (69070-306-01) / 15 g in 1 TUBE

Ingredients (3)

diphenhydramine hydrochloride (2 g/100g) ferric oxide red (.05 g/100g) zinc oxide (9.95 g/100g)

Linked Drug Pages (1)

Au Kah Chuen Fugical ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4345b4b7-3e93-9d68-e063-6294a90a7d77", "openfda": {"unii": ["TC2D6JAD40", "1K09F3G675", "SOI2LOH54Z"], "rxcui": ["2727332"], "spl_set_id": ["5b4add17-6c3d-4093-826a-2edb41c1d1db"], "manufacturer_name": ["Zhejiang Dingtai Pharmaceutical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69070-306-01)  / 15 g in 1 TUBE", "package_ndc": "69070-306-01", "marketing_start_date": "20190610"}], "brand_name": "Au Kah Chuen Fugical", "product_id": "69070-306_4345b4b7-3e93-9d68-e063-6294a90a7d77", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69070-306", "generic_name": "Calamine and Diphenhydramine hydrochlorid", "labeler_name": "Zhejiang Dingtai Pharmaceutical Co., Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Au Kah Chuen Fugical", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "2 g/100g"}, {"name": "FERRIC OXIDE RED", "strength": ".05 g/100g"}, {"name": "ZINC OXIDE", "strength": "9.95 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190610", "listing_expiration_date": "20261231"}