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  4. NDC Product Code: 82652-021 Diphen

NDC 82652-021 Diphen

Benzocaine,Benzalkonium Chloride,Lidocaine Hydrochloride,Hydrocortisone,Bacitracin - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82652-021?
  5. Diphen Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
82652-021
Proprietary Name:
Diphen
Non-Proprietary Name: [1]
Benzocaine, Benzalkonium Chloride, Lidocaine Hydrochloride, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, And Bismuth Subsalicylate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Remedy Pack Llc
Labeler Code:
82652
Product Label ID:
5d185f23-8af6-4e36-b514-5662986520a5
FDA Application Number: [6]
ANDA076134
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-10-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
BROWN (C48332)
PINK (C48328)
YELLOW (C48330)
Shape:
ROUND (C48348)
CAPSULE (C48336)
Size(s):
11 MM
10 MM
6 MM
12 MM
9 MM
16 MM
Imprint(s):
AZ;036
44;291
RX;526
FR;12
048;D
44;403
FR;33
RH;046
Score:
1
Flavor(s):
PEPPERMINT (C73408)

Code Structure Chart

Product Details

What is NDC 82652-021?

The NDC code 82652-021 is assigned by the FDA to the product Diphen which is a human over the counter drug product labeled by Remedy Pack Llc. The generic name of Diphen is benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 82652-021-01 1 kit in 1 carton * 1 tablet, film coated in 1 packet (82652-022-01) * 2 tablet, film coated in 1 packet (82652-025-01) * 2 tablet in 1 packet (82652-030-01) * 2 tablet in 1 packet * 1 tablet, film coated in 1 packet (82652-031-01) * 2 tablet in 1 packet (82652-032-01) * 2 tablet, chewable in 1 packet (82652-026-01) * 2 tablet, film coated in 1 packet (82652-024-01) * 2 tablet, chewable in 1 packet (82652-023-01) * .5 g in 1 packet (82652-028-01) * .9 g in 1 packet (82652-027-01) * .9 g in 1 packet (82652-029-01) * .75 g in 1 packet (82652-033-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Diphen?

Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Which are Diphen UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Diphen Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Diphen?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream
  • RxCUI: 1043690 - hydrocortisone acetate 1 % Topical Cream
  • RxCUI: 1043690 - hydrocortisone acetate 10 MG/ML Topical Cream

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".