NDC 58599-003 Diphenhydramine

NDC Product Code 58599-003

NDC CODE: 58599-003

Proprietary Name: Diphenhydramine 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.

Product Characteristics

Color(s):
PINK (C48328 - PINK CAP AND WHITE BODY)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
DH;25
Score: 2

NDC Code Structure

NDC 58599-003-25

Package Description: 1 BOTTLE in 1 CARTON > 50 CAPSULE in 1 BOTTLE

NDC 58599-003-29

Package Description: 1 BOTTLE in 1 CARTON > 100 CAPSULE in 1 BOTTLE

NDC 58599-003-35

Package Description: 1 BOTTLE in 1 CARTON > 1000 CAPSULE in 1 BOTTLE

NDC 58599-003-90

Package Description: 50000 CAPSULE in 1 BOX

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Diphenhydramine with NDC 58599-003 is a product labeled by Purinepharma Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1049909.

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.

  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Labeler Information

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

Labeler Name: Purinepharma Llc
Labeler Code: 58599
Start Marketing Date: 07-31-2014 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
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 als...
[Read More]

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Diphenhydramine 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

Otc - Active Ingredient

Active Ingredient (each banded capsule contains)Diphenhydramine HCL 25 mg

Otc - Purpose

PurposeAntihistaminne

Indications & Usage

  • Usestemporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, Watery eyesitching of the nose or throat

Otc - Ask Doctor

  • Ask a doctor before use if you havea breathing problem such as chronic bronchitisglaucomatrouble urinating due to an enlarged prostate gland

Otc - Do Not Use

Do not use to make a child sleepyDo not use with any other product containing diphenhydramine, even one used on skin

Otc - When Using

  • When using this productmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, In case of overdose, get medical help or contact a Poison control center right away.

Dosage & Administration

  • Directions: Take every 4 to 6 hours.Do not take more than 6 doses in any 24-hour period.Adults and Children 12 years of age and over1 to 2 capsulesChildren 6 to under 12 years of age1 capsuleChildren under 6 years of ageDo not use

Storage And Handling

  • Other informationStore between 15-30 degree Celsius (59-86 degree Fahrenheit)Protect from moisture

Inactive Ingredient

D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

How Supplied

Pack Size: 50 Capsules in a Bottle
Batch No.:
Mfg. Date:
Exp. Date:

Other Safety Information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

* Please review the disclaimer below.