Diphenhydramine Hcl 25 Mg Capsule
NDC Package 69618-024-01
Package Information
Diphenhydramine Hcl 25 Mg (diphenhydramine hcl) capsules is diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a capsule delivery system. Marketed by Reliable 1 Laboratories Llc, this product is identified by NDC 69618-024 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
- RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 69618 - Reliable 1 Laboratories Llc
- 69618-024 - Diphenhydramine Hcl 25 Mg
- 69618-024-01 - 100 CAPSULE in 1 BOTTLE, PLASTIC
- 69618-024 - Diphenhydramine Hcl 25 Mg
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 69618-024-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Diphenhydramine Hcl 25 Mg, a human over the counter drug labeled by Reliable 1 Laboratories Llc. This capsule is formulated for oral use and contains diphenhydramine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Reliable 1 Laboratories Llc on November 01, 2015. The current certification is valid through December 31, 2026.
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 Reliable 1 Laboratories Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 69618002401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.