MedPath

Allergy Relief

CDMA-Diphenhydramine Hydrochloride capsules, 25 mg-dye free

Approved
Approval ID

395bb39a-e26f-f4f2-e063-6394a90ae721

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

CHAIN DRUG MARKETING ASSOCIATION INC.

DUNS: 011920774

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 Code83324-280
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (8)

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: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

24's count

QC**®**

Quality Choice

NDC 83324-280-24

*Compare to the Active

Ingredient in Benadryl**®**

Allergy LIQUI-GELS**®†**

Dye-Free

Allergy Relief

Diphenhydramine HCl Capsules USP, 25 mg

Antihistamine

Relieves:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 softgels**

**liquid-filled capsules

image001

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/25/2024

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/26/2024

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/26/2024

Questions or comments?

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/25/2024

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/25/2024

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 11/25/2024

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: 11/25/2024

Do not use

■ Do not use for children under 6 years of age ■ with any other product containing diphenhydramine, even one used on skin.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 11/25/2024

Ask a doctor before use if you have

■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 11/25/2024

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 11/25/2024

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 11/25/2024

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 11/25/2024

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/25/2024

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/25/2024

Directions

■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 years

do not use this product for children under 6 years of age

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 11/26/2024

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/7/2025

THIS PRODUCT IS PACKAGED IN A TAMPER EVIDENT PACKAGE.
** USE ONLY IF BLISTERS ARE INTACT.**

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by the owners of Benadryl® Allergy Liqui-gels®.

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

MADE IN INDIA

Mfg. Lic. No: TN00002123

29006636

L0001048

R0525

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Allergy Relief - FDA Drug Approval Details