Whiteactivatingcream Cream, Augmented
NDC 84423-074
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Whiteactivatingcream is a OTC MONOGRAPH DRUG-approved product labeled by Guangzhou Kadiya Biotechnology Co., Ltd.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a cream, augmented for cutaneous administration. This product entry covers the primary NDC 84423-074 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
84423-074
Proprietary Name:
Whiteactivatingcream
Non-Proprietary Name: [1]
Whiteactivatingcream
Substance Name: [2]
Ethylhexyl Salicylate; Gynostemma Pentaphyllum Whole; Niacinamide; Sophora Flavescens Root; Stephania Tetrandra Whole; Vincetoxicum Atratum Whole
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Cream, Augmented
- A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered "augmented”.
Administration Route(s): [4]
Cutaneous - Administration to the skin.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
84423
Product Label ID:
FDA Application Number: [6]
M016
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
02-18-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 84423-074?
The NDC code 84423-074 is assigned by the FDA to the product Whiteactivatingcream. This pharmaceutical product is labeled by Guangzhou Kadiya Biotechnology Co., Ltd. and is currently categorized as listed product. The medication is a cream, augmented administered via cutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 84423-074-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Cleanse your skin with warm water and pat dry apply a thin layer ofour Exclusive White and Activating Cream on affected areas, gently massage your skin and let it dry
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- ETHYLHEXYL SALICYLATE 1 g/50mL
- GYNOSTEMMA PENTAPHYLLUM WHOLE .15 g/50mL
- NIACINAMIDE .05 g/50mL - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
- SOPHORA FLAVESCENS ROOT .25 g/50mL
- STEPHANIA TETRANDRA WHOLE .15 g/50mL
- VINCETOXICUM ATRATUM WHOLE .25 g/50mL
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- GYNOSTEMMA PENTAPHYLLUM WHOLE (UNII: CHC1JS541R)
- GYNOSTEMMA PENTAPHYLLUM WHOLE (UNII: CHC1JS541R) (Active Moiety)
- STEPHANIA TETRANDRA WHOLE (UNII: 7S7TV2F4XC)
- STEPHANIA TETRANDRA WHOLE (UNII: 7S7TV2F4XC) (Active Moiety)
- ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W)
- ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (Active Moiety)
- SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
- SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (Active Moiety)
- NIACINAMIDE (UNII: 25X51I8RD4)
- NIACINAMIDE (UNII: 25X51I8RD4) (Active Moiety)
- VINCETOXICUM ATRATUM WHOLE (UNII: U3176B0S5J)
- VINCETOXICUM ATRATUM WHOLE (UNII: U3176B0S5J) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- CETEARYL PHOSPHATE (UNII: 4O6GCK4CTJ)
- CARBOMER (UNII: 0A5MM307FC)
- AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
- 1,3-BUTYLENEGLYCOL DIMETHACRYLATE (UNII: OL56191M6N)
- C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
- AQUA (UNII: 059QF0KO0R)
- CETEARYL ALCOHOL (UNII: 2DMT128M1S)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- PANTHENOL (UNII: WV9CM0O67Z)
- TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
- C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
- C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)
- POLYGLYCERIN-10 (UNII: P9060O936A)
- HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
- POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
- LAURETH-7 (UNII: Z95S6G8201)
- BHT (UNII: 1P9D0Z171K)
- DIMETHICONE (UNII: 92RU3N3Y1O)
- POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
- ZINC OXIDE (UNII: SOI2LOH54Z)
- GLYCERIN (UNII: PDC6A3C0OX)
- POLYGLYCERYL-10 DIPALMITATE (UNII: 84VD0IA2S6)
- 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
- XANTHAN GUM (UNII: TTV12P4NEE)
- OXYBENZONE (UNII: 95OOS7VE0Y)
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
