NDC 71309-009 Allergy Relief

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
71309-009
Proprietary Name:
Allergy Relief
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Safrel Pharmaceuticals, Llc.
Labeler Code:
71309
Start Marketing Date: [9]
05-12-2012
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
Shape:
CAPSULE (C48336)
Size(s):
11 MM
Imprint(s):
EL
Score:
1

Product Packages

NDC Code 71309-009-01

Package Description: 1000 TABLET in 1 BOTTLE

NDC Code 71309-009-06

Package Description: 600 TABLET in 1 BOTTLE

NDC Code 71309-009-10

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 71309-009-30

Package Description: 1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE

Product Details

What is NDC 71309-009?

The NDC code 71309-009 is assigned by the FDA to the product Allergy Relief which is product labeled by Safrel Pharmaceuticals, Llc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 71309-009-01 1000 tablet in 1 bottle , 71309-009-06 600 tablet in 1 bottle , 71309-009-10 100 tablet in 1 bottle , 71309-009-30 1 bottle in 1 carton / 30 tablet in 1 bottle. 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 Allergy Relief?

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 Allergy Relief UNII Codes?

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

  • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
  • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

Which are Allergy Relief 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 Allergy Relief?

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:

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Patient Education

Diphenhydramine


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 also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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Product Footnotes

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

[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".