NDC 71594-700 Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels


NDC Product Code 71594-700

NDC CODE: 71594-700

Proprietary Name: Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels 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 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

  • 71594 - Uspharma Ltd
    • 71594-700 - Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels

NDC 71594-700-04

Package Description: 14 CHEWABLE GEL in 1 BOTTLE

NDC Product Information

Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels with NDC 71594-700 is a a human over the counter drug product labeled by Uspharma Ltd. The generic name of Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels is diphenhydramine. The product's dosage form is chewable gel and is administered via oral form.

Labeler Name: Uspharma Ltd

Dosage Form: Chewable Gel -

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.

Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels 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.

  • SUCROSE (UNII: C151H8M554)
  • 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.

  • Oral - Administration to or by way of the mouth.
  • 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: Uspharma Ltd
Labeler Code: 71594
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: 05-01-2020 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: 12-31-2021 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.

Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels Product Label Images

Firstcare Childrens Allergy Diphenhydramine Hcl Chewable Gels 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 Ingredient (In Each Chewable Gel)

Diphenhydramine HCl 12.5 mg




  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Runny noseItchy, watery eyesSneezingItching of the nose or throat


  • Do not useTo make child sleepywith any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • A breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate gland

When Using This Product

  • Excitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery


  • Take every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursInstruct child to chew each chewable gel thoroughly before swallowingfind right dose on chart below
  • Age (yr)Dose (chewable gels)Children under 2 yearsDo not useChildren 2 to 5 yearsDo not use unless directed by a doctorChildren 6 to 11 years1 to 2 chewable gels (12.5 mg to 25 mg)Adults and children 12 years and over2 to 4 chewable gels (25 mg to 50 mg)

Inactive Ingredients:

Trisodium citrate dihydrate, sodium chloride, sucralose, neotame, glucose syrup, seaweed extract (carrageenan), maltitol solution, hydroxypropyl betadex, maltodextrin, flavor, sucrose, mineral oil, starch, citric acid, purified water.

* Please review the disclaimer below.