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NDC 00904-7237-24 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 Major Pharmaceuticals. 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: 00904-7237-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00904-7237
Product ID	0904-7237_dca04d80-e782-40b1-e053-2995a90a7010
Associated GPIs
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	Major Pharmaceuticals
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 00904-7237-24 (00904723724)

Pricing Information
NDC Package Code	0904-7237-24
Billing NDC	00904723724
Package	2 BLISTER PACK in 1 CARTON (0904-7237-24) / 12 CAPSULE in 1 BLISTER PACK
Marketing Start Date	2022-04-14
NDC Exclude Flag	N
Price Per Unit	0.04208
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	BANOPHEN 25 MG CAPSULE
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

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 dca04d80-e781-40b1-e053-2995a90a7010 Details

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

 to make a child sleepy

 with any other product 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 an enlarged 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

 be careful 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 (1-800-222-1222).

Directions

 take every 4 to 6 hours, or as directed by a doctor

 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 in a dry place at 15° – 30°C (59° – 86°F)

SPL UNCLASSIFIED SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

SPL UNCLASSIFIED SECTION

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE

TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

Major

BENOPHEN

NDC 0904-7237-80

Complete Allergy Medication

Diphenhydramin HCl 25 mg

Antihistamine

For the temporary relief of the symptoms of:

• Upper Respiratory Allergies

• Hay Fever

Compare to the active ingredient in BENADRYL®*

1000 CAPSULES

EACH CAPSULE INDIVIDUALLY

BANDED FOR YOUR PROTECTION

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7237
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-7237-80	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2022
2	NDC:0904-7237-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2022
3	NDC:0904-7237-24	2 in 1 CARTON	04/14/2022
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0904-7237-61	10 in 1 BOX, UNIT-DOSE	04/14/2022
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/14/2022

Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2022

Document Id: dca04d80-e782-40b1-e053-2995a90a7010

Set id: dca04d80-e781-40b1-e053-2995a90a7010

Version: 1

Effective Time: 20220414

Search by Drug Name or NDC

NDC 00904-7237-24 Diphenhydramine Hydrochloride 25 mg/1 Details

Diphenhydramine Hydrochloride 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-7237-24 (00904723724)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dca04d80-e781-40b1-e053-2995a90a7010 Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Directions

Other information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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