MedPath

Allergy Relief

walgreens-Diphenhydramine HCl Capsules, 50 mg dye free

Approved
Approval ID

2969ba8f-c477-222a-e063-6394a90af703

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

WALGREEN COMPANY

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-6123
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (9)

POLYETHYLENE GLYCOL 600Inactive
Code: NL4J9F21N9
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

carton

Walgreens

Compare to the active ingredient in

Benadryl® Allergy Extra Strength

EXTRA STRENGTH

Allergy

Relief

DIPHENHYDRAMINE HCl CAPSULES USP,

50 mg/ANTIHISTAMINE

Dye-Free Extra Strength

Sneezing, itchy, watery eyes;

runny nose & itchy throat or nose

100

SOFTGELS**

(** liquid-filled capsules)

carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2025

Uses

•temporarily relieves these symptoms due to hay fever or the other upper respiratory allergies:
• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 4/30/2024

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/22/2025

When using this product

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/22/2025

Stop use and ask a doctor if

sleeplessness persists continuosly for more than 2 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/22/2025

If pregnant or breast- feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/22/2025

Keep out of reach of children.

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/30/2024

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/22/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 4/30/2024

Warnings

• May cause excitability especially in children.
• May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/22/2025

Do not use

• for children under 12 years of age • with any other product conaining diphenhydramine, even one used on skin.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/22/2025

Ask a doctor before use if you have

■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/22/2025

Directions

adults and children 12 years and over

• take 1 capsule every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 capsules in 24 hours

children under 12 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/22/2035

Other information

■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/16/2025

Inactive ingredients

gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/30/2024

Questions or comments?

call toll-free1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2025

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING.

** KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION**

ƚOur pharmacists recommend the Walgreens brand.

We invite you to compare to national brands.

ƚƚThis product is not manufactured or distributed by Kenvue, Inc.,

owner of the registered trademark Benadryl ® Allergy Extra Strength.

DISTRIBUTED BY: WALGREENS CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

wlagreens.com

©2024 Walgreen Co,MADE IN INDIA

Mfg. Lic. No.: TN00002123

L0000957

R0125

Lot No.:

Exp. Date:

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Allergy Relief - FDA Drug Approval Details