NDC 71101-215 Theracare Extra Strength Anti-itch Cream Itch Stopping

Diphenhydramine Hydrochloride And Zinc Acetate

NDC Product Code 71101-215

NDC CODE: 71101-215

Proprietary Name: Theracare Extra Strength Anti-itch Cream Itch Stopping 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

  • 71101 - Veridian Healthcare
    • 71101-215 - Theracare Extra Strength Anti-itch Cream

NDC 71101-215-01

Package Description: 1 TUBE in 1 CARTON > 35.4 g in 1 TUBE

NDC Product Information

Theracare Extra Strength Anti-itch Cream Itch Stopping with NDC 71101-215 is a a human over the counter drug product labeled by Veridian Healthcare. The generic name of Theracare Extra Strength Anti-itch Cream Itch Stopping is diphenhydramine hydrochloride and zinc acetate. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1087026.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Theracare Extra Strength Anti-itch Cream Itch Stopping 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.

  • 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: Veridian Healthcare
Labeler Code: 71101
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: 09-01-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Theracare Extra Strength Anti-itch Cream Itch Stopping Product Label Images

Theracare Extra Strength Anti-itch Cream Itch Stopping 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

Otc - Purpose

Active ingredientsPurposeDiphenhydramine hydrochloride 2%Topical analgesicZinc acetate 0.1%Skin protectant


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


For external use only

Otc - Do Not Use

  • Do not useon large areas of the bodywith any other product containing diphenhydramine, even one taken by mouth

Otc - Ask Doctor

  • Ask a doctor before useon chicken poxon measles

Otc - When Using

  • When using this productuse only as directedavoid contact with eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition 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. (1-800-222-1222)


  • Adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times dailychildren under 2 years of age: consult a physician

Other Information

  • Store at 20°C-25°C (68°C/77°F) do not use if tube seal under cap is broken

Inactive Ingredients

Cetyl alcohol, di sodium edetate, Diazolidinyl urea, methylparaben, peg-100 stearate, peg-2 stearate, petrolatum, potassium hydroxide, polyethylene glycol, propylparaben, stearic acid, water


Toll-free 866-326-1313

* Please review the disclaimer below.