Allergy Relief
NDC Package 49348-162-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Allergy Relief is diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. Marketed by Strategic Sourcing Services Llc, this product is identified by NDC 49348-162 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
49348-162-04
Package Description
24 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code
11-Digit Billing Format
49348016204
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA

Clinical Specifications

Proprietary Name
Allergy Relief
Dosage Form
-
Usage Information
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).

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services Llc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-30-2015
End Marketing Date
12-31-2020
Listing Expiration
12-31-2020
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49348-162). Click a package code to view its specific billing and regulatory data.

100 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49348-162-04 identifies a specific commercial package of 24 blister pack in 1 carton / 1 capsule in 1 blister pack of Allergy Relief, labeled by Strategic Sourcing Services Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 24 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Strategic Sourcing Services Llc on September 30, 2015. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

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).

How is this Strategic Sourcing Services Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348016204. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49348-162-04
11-Digit CMS (5-4-2)
49348-0162-04

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.