NDC 63742-012 Numb520

Lidocaine Hydrochloride, Phenylephrine Hydrochloride

NDC Product Code 63742-012

NDC Code: 63742-012

Proprietary Name: Numb520 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine Hydrochloride, Phenylephrine Hydrochloride 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.

NDC Code Structure

  • 63742 - Clinical Resolution Laboratory, Inc.
    • 63742-012 - Numb520

NDC 63742-012-00

Package Description: 72 mL in 1 BOTTLE

NDC Product Information

Numb520 with NDC 63742-012 is a a human over the counter drug product labeled by Clinical Resolution Laboratory, Inc.. The generic name of Numb520 is lidocaine hydrochloride, phenylephrine hydrochloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Clinical Resolution Laboratory, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Numb520 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.


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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Clinical Resolution Laboratory, Inc.
Labeler Code: 63742
FDA Application Number: part346 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-01-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Numb520 Product Label Images

Numb520 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Lidocaine HCL 5%Phenylephrine HCL, 0.25%


Local AnestheticVasoconstrictor


For the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.


  • For external use only.avoid contact with the eyes.

Do Not Use This Product If

  • Pregnant or breastfeeding, ask a health professional before use.Tamper Evident "Do not use this product" if safety seal is broken or missing.you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

When Using This Product

  • Do not exceed the recommended daily usage.certain persons can develop allergic reactions to ingredients in this product.do not put this product into the rectum by using fingers or any medical device or applicator.if swallowed, call your Poison Control Center at 1(800) 222-1222.if condition worsens or does not improve within 7 days, consult a doctor.

Stop Use And Ask A Doctor If

  • The symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.


  • Clean the affected area.sensitivity and possible allergy tests advised prior to use. Spray spraingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.apply to the affected area up to 4 times daily.children under 12 years of age, consult a doctor.

Other Information

  • Keep away from direct sunlight or heat.store in room temperature (59-86°F / 15-30°C).

Inactive Ingredients

Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite

* Please review the disclaimer below.

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