NDC 58602-517 Dye-free Adult Allergy Liquid Medication

Diphenhydramine Hydrochloride

NDC Product Code 58602-517

NDC CODE: 58602-517

Proprietary Name: Dye-free Adult Allergy Liquid Medication 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: Diphenhydramine 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

  • 58602 - Aurohealth Llc
    • 58602-517 - Dye-free Adult Allergy Liquid Medication

NDC 58602-517-24

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Dye-free Adult Allergy Liquid Medication with NDC 58602-517 is a a human over the counter drug product labeled by Aurohealth Llc. The generic name of Dye-free Adult Allergy Liquid Medication is diphenhydramine hydrochloride. The product's dosage form is solution and is administered via oral form.

Labeler Name: Aurohealth Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Dye-free Adult Allergy Liquid Medication 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CHERRY (UNII: BUC5I9595W)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Aurohealth Llc
Labeler Code: 58602
FDA Application Number: part341 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: 09-24-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 08-01-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

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Dye-free Adult Allergy Liquid Medication 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

Drug Facts

Active ingredient [in each 20 mL] Diphenhydramine HCl, USP 50 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezingitchy, watery eyesrunny noseitching of the nose or throat

Warnings

  • Do not useto make a child sleepy with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • A breathing problem such as chronic bronchitisglaucomaa sodium-restricted diettrouble urinating due to enlarged prostateAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • Marked drowsiness may occuravoid alcoholic drinkssedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenIf pregnant or breast feeding, ask a health professional before use

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hours not to exceed 300 mg in 24 hoursmL = milliliterAge (yr)Dose (mL)Adult and children 12 years and older10 mL to 20 mLChildren under 12 yearsConsult a doctorAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • Each 20 mL contains: sodium 56 mgstore between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date

Inactive Ingredients

Anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucraloseQuestions or Comments? 1-855-274-4122  Distributed by: AUROHEALTH LLC. 2572 Brunswick Pike Lawrenceville, NJ 08648

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