MedPath

Allergy Relief

Equate 44-614 Delisted

Approved
Approval ID

ba0fa9f9-7778-4a51-9ad1-fb349ceb8121

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

Wal-Mart Stores Inc

DUNS: 051957769

Products 1

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

Diphenhydramine HCI

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49035-164
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCI
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (10)

DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

Principal display panel

equate™

NDC 49035-164-12

Compare to Benadryl® Allergy Ultratabs® Active Ingredient*

Dye Free
Allergy Relief
Diphenhydramine HCI, 25 mg
Antihistamine

Allergy relief for:
• Sneezing • Itchy, watery eyes
• Runny nose • Itchy throat

25
mg
EACH

100
TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Satisfaction guaranteed – For questions
or comments please call1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Benadryl® Allergy Ultratabs®.
50844 REV0422B61412

Equate 44-614

Equate 44-614

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/28/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/28/2025

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/28/2025

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/28/2025

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 chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/28/2025

Directions

*do not take more than directed

  • 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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/28/2025

Other information

***each tablet contains:**calcium 30 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/28/2025

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/28/2025

Questions or comments?

1-888-287-1915

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Allergy Relief - FDA Drug Approval Details