NDC 68007-403 Zhuifeng Gao Pain Relieving

Menthol

NDC Product Code 68007-403

NDC 68007-403-01

Package Description: 2 POUCH in 1 BOX > 5 PLASTER in 1 POUCH

NDC Product Information

Zhuifeng Gao Pain Relieving with NDC 68007-403 is a a human over the counter drug product labeled by Guilin China Resources Tianhe Pharmaceutical Co Ltd. The generic name of Zhuifeng Gao Pain Relieving is menthol. The product's dosage form is plaster and is administered via transdermal form.

Labeler Name: Guilin China Resources Tianhe Pharmaceutical Co Ltd

Dosage Form: Plaster - Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin.

Product Type: Human Otc Drug 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.

Zhuifeng Gao Pain Relieving Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 35 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • OCIMUM GRATISSIMUM WHOLE (UNII: 7V3N80T4VS)
  • CHINESE CINNAMON (UNII: WS4CQ062KM)
  • CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)
  • PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • DRAGON'S BLOOD (UNII: M3YJ2C28IC)
  • ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
  • FRANKINCENSE (UNII: R9XLF1R1WM)
  • PIPER KADSURA STEM (UNII: 80IOP41EL7)
  • KNOXIA ROXBURGHII SUBSP. BRUNONIS ROOT (UNII: LR7SZ0O0B9)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LESSER GALANGAL ROOT (UNII: 42LD90786Y)
  • LINDERA AGGREGATA ROOT (UNII: 517Q7XRT2T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • MYRRH (UNII: JC71GJ1F3L)
  • NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)
  • PAPRIKA (UNII: X72Z47861V)
  • PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3)
  • PRUNUS PERSICA SEED (UNII: V9C81470RR)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)
  • ROSIN (UNII: 88S87KL877)
  • NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
  • SAFFLOWER (UNII: 4VBL71TY4Y)
  • BIANCAEA SAPPAN WOOD (UNII: 086263LQDD)
  • DIPSACUS ASPER ROOT (UNII: LB1GQP4253)
  • STYRENE (UNII: 44LJ2U959V)
  • ISOPRENE (UNII: 0A62964IBU)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Guilin China Resources Tianhe Pharmaceutical Co Ltd
Labeler Code: 68007
FDA Application Number: part348 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 05-11-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Zhuifeng Gao Pain Relieving Product Label Images