NDC 54868-1986 Guaifenesin DM
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 54868-1986?
What are the uses for Guaifenesin DM?
Which are Guaifenesin DM UNII Codes?
The UNII codes for the active ingredients in this product are:
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- GUAIFENESIN (UNII: 495W7451VQ)
- GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)
Which are Guaifenesin DM Inactive Ingredients 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:
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
- GLUCOSE OXIDASE (UNII: 0T8392U5N1)
- WATER (UNII: 059QF0KO0R)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
What is the NDC to RxNorm Crosswalk for Guaifenesin DM?
- RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution
* Please review the disclaimer below.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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".