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NDC 70000-0207-02 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

Diphenhydramine Hydrochloride is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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.

Related Packages: 70000-0207-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70000-0207
Product ID	70000-0207_c4fcd8bc-0bb7-c0a3-e053-2995a90a8b49
Associated GPIs	41200030100105
GCN Sequence Number	011582
GCN Sequence Number Description	diphenhydramine HCl CAPSULE 25 MG ORAL
HIC3	Z2P
HIC3 Description	ANTIHISTAMINES - 1ST GENERATION
GCN	45971
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Diphenhydramine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Cardinal Health
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0207-02 (70000020702)

Pricing Information
NDC Package Code	70000-0207-2
Billing NDC	70000020702
Package	100 CAPSULE in 1 BOTTLE (70000-0207-2)
Marketing Start Date	2017-03-28
NDC Exclude Flag	N
Price Per Unit	0.04126
Pricing Unit	EA
Effective Date	2024-01-17
NDC Description	ALLERGY 25 MG CAPSULE
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-14

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 2e3b4e65-d090-4e44-9c03-60c3064b74fa Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

(in each banded capsule)

Diphenhydramine Hydrochloride 25mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing; itchy
watery eyes
itching of the nose or throat

Temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

Warnings

Do not use

to make child sleepy
with any other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
excitability may occur, especially in children

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over	1 to 2 capsules
children 6 to under 12 years of age	1 capsule
children under 6 years of age	do not use this product in children under 6 years of age

Other Information

store at room temperature, USP

SPL UNCLASSIFIED SECTION

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

Questions or Comments?

(800) 231-4670

SPL UNCLASSIFIED SECTION

Distributed By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

Essential to Care™ since 1979

+This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl®

© 2016 Cardinal Health. All rights Reserved. Cardinal Health, the Cardinal Health Logo, Leadear and the Leader Logo are trademarks or registered trademarks of Cardinal Health. All other marks are property of their respective owners.

PRINCIPAL DISPLAY PANEL

NDC 70000-0207-1

Allergy Capsules

Diphenhydramine HCL, 25 mg

Antihistamine

For Allergy Relief

Runny Nose, Itchy Throat, Sneezing and Itchy, Watery Eyes

24 Capsules

Compare to Benadryl® active ingredient+

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0207
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (Half pink and half clear with white powder inside)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC;835
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0207-1	2 in 1 CARTON	01/31/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0207-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/13/2017

Labeler - Cardinal Health (063997360)

Revised: 6/2021

Document Id: c4fcd8bc-0bb7-c0a3-e053-2995a90a8b49

Set id: 2e3b4e65-d090-4e44-9c03-60c3064b74fa

Version: 5

Effective Time: 20210617

Search by Drug Name or NDC

NDC 70000-0207-02 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70000-0207-02 (70000020702)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2e3b4e65-d090-4e44-9c03-60c3064b74fa Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if

When using this product

If pregnant or breast-feeding

Keep out of reach of children.

Directions

Other Information

SPL UNCLASSIFIED SECTION

Questions or Comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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