Cvs Mini Enema Liquid
NDC 51316-991
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Cvs Mini Enema (docusate sodium w/benzocaine) is a OTC MONOGRAPH DRUG-approved product labeled by Cvs Health. This medication is typically used as a allergens [cs]. It is supplied as a liquid for rectal administration. This product entry covers the primary NDC 51316-991 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
51316-991
Proprietary Name:
Cvs Mini Enema
Non-Proprietary Name: [1]
Docusate Sodium W/benzocaine
Substance Name: [2]
Benzocaine; Docusate Sodium
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Liquid
- A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Rectal - Administration to the rectum.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
51316
Product Label ID:
FDA Application Number: [6]
M007
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
08-20-2021
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 51316-991?
The NDC code 51316-991 is assigned by the FDA to the product Cvs Mini Enema. It is commonly known by its generic name, docusate sodium w/benzocaine. This pharmaceutical product is labeled by Cvs Health and is currently categorized as listed product. The medication is a liquid administered via rectal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 51316-991-05. 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?
Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children under 12 years of age, consult a doctor prior to use.Twist off and remove tip.Lubricate tip prior to insertion: Place a few drops of the tube’s liquid content on the shaft prior to insertion. Also apply liquid content or lubricant to the anus before inserting the mini-enema.Positioning: For best results, lay on the left side with knees bent. Alternate Positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface.With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Insert up to the shoulder of tube. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.
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.
- BENZOCAINE 20 mg/5mL - A surface anesthetic that acts by preventing transmission of impulses along NERVE FIBERS and at NERVE ENDINGS.
- DOCUSATE SODIUM 283 mg/5mL - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- DOCUSATE SODIUM (UNII: F05Q2T2JA0)
- DOCUSATE (UNII: M7P27195AG) (Active Moiety)
- BENZOCAINE (UNII: U3RSY48JW5)
- BENZOCAINE (UNII: U3RSY48JW5) (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:
- POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
- GLYCERIN (UNII: PDC6A3C0OX)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1192984 - docusate sodium 283 MG / benzocaine 20 MG in 5 mL Enema
- RxCUI: 1192984 - benzocaine 4 MG/ML / docusate sodium 56.6 MG/ML Enema
- RxCUI: 1192984 - benzocaine 20 MG / docusate sodium 283 MG per 5 ML Enema
- RxCUI: 1192984 - Benzocaine 4 MG/ML / DOSS Sodium 56.6 MG/ML Enema
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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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".
