Wu Yang Brand Pain Relieving Medicated with NDC 55614-700 is a a human over the counter drug product labeled by Madison One Acme Inc. The generic name of Wu Yang Brand Pain Relieving Medicated is menthol and camphor. The product's dosage form is plaster and is administered via transdermal form.
Labeler Name: Madison One Acme Inc
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.
Wu Yang Brand Pain Relieving Medicated 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 5 g/100g
- CAMPHOR (SYNTHETIC) 3 g/100g
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.
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- DIPSACUS ASPER ROOT (UNII: LB1GQP4253)
- DRAGON'S BLOOD (UNII: M3YJ2C28IC)
- DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
- GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
- LANOLIN (UNII: 7EV65EAW6H)
- LIGHT MINERAL OIL (UNII: N6K5787QVP)
- LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
- METHYL SALICYLATE (UNII: LAV5U5022Y)
- MYRRH (UNII: JC71GJ1F3L)
- NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
- PETROLATUM (UNII: 4T6H12BN9U)
- POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)
- RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)
- ROSIN (UNII: 88S87KL877)
- SAFFLOWER (UNII: 4VBL71TY4Y)
- SENEGALIA CATECHU WOOD (UNII: CHL342Y4LA)
- TARAXACUM MONGOLICUM WHOLE (UNII: 4E8QL88U6H)
- 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: Madison One Acme Inc
Labeler Code: 55614
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: 08-31-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.
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