NDC 69968-0459 Benadryl Extra Strength Itch Relief

Diphenhydramine Hydrochloride And Zinc Acetate

NDC Product Code 69968-0459

NDC Code: 69968-0459

Proprietary Name: Benadryl Extra Strength Itch Relief 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 And Zinc Acetate 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

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0459 - Benadryl Extra Strength Itch Relief

NDC 69968-0459-1

Package Description: 1 APPLICATOR in 1 CARTON > 14 mL in 1 APPLICATOR

NDC Product Information

Benadryl Extra Strength Itch Relief with NDC 69968-0459 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Benadryl Extra Strength Itch Relief is diphenhydramine hydrochloride and zinc acetate. The product's dosage form is solution and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

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.

Benadryl Extra Strength Itch Relief 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 20 mg/mL
  • ZINC ACETATE 1 mg/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROMETHAMINE (UNII: 023C2WHX2V)

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: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
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: 06-01-2019 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.

Benadryl Extra Strength Itch Relief Product Label Images

Benadryl Extra Strength Itch Relief 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

Other

Drug Facts

Distributed by:JOHNSON & JOHNSON CONSUMER INC.Skillman, NJ 08558

Otc - Purpose

Active ingredientPurposeDiphenhydramine HCl 2%Topical analgesic Zinc acetate 0.1%Skin protectant

Uses

  • Temporarily relieves pain and itching associated with:insect bitesminor burnssunburnminor skin irritationsminor cutsscrapesrashes due to poison ivy, poison oak, and poison sumacdries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.Flammable. Keep away from fire or flame.

Do Not Use

  • On large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

  • On chicken poxon measles

Otc - When Using

When using this product avoid contact with eyes

Stop Use And Ask A Doctor If

  • Condition worsens or does not improve within 7 dayssymptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Do not use more than directedhold stick straight down over affected skin areapress tip of stick repeatedly on affected skin area until liquid flows, then dab sparingly adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: ask a doctor

Other Information

  • Store at 20° to 25° C (68° to 77° F)

Inactive Ingredients

Alcohol, water, PVP, glycerin, tromethamine

Questions?

Call 1-800-524-2624 (English/Spanish)

* Please review the disclaimer below.

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