MedPath

Benadryl Allergy

Benadryl Allergy

Approved
Approval ID

7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

JC World Bell Wholesale Co., Inc.

DUNS: 805257581

Products 1

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

DIPHENHYDRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50269-528
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (11)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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: 8/29/2025

Package Labeling:

Corton LabelPacket label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/29/2025

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 common cold:
  • runny nose
  • sneezing

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/30/2025

Other information

***each tablet contains:**calcium 15 mg

  • store between 20-25°C (68°-77°F). Protect from light. *do not use if pouch is torn or damaged

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/29/2025

Active ingredient (in each tablet)

Diphenydramine HCl 25mg

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 8/29/2025

Warnings

Do not use

  • 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 bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilzers

When using this product

  • marked drawsiness 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, espesially 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)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/29/2025

Directions

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

adults and children 12 years and over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/29/2025

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C red no.27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/29/2025

Questions or comments?

call1-877-717-2824(toll-free)or 215-273-8755(collect)

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