FDA.reportPublic FDA data

Benadryl Allergy Extra Strength Liqui-Gels

Manufacturer
Kenvue Brands LLC
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:25:34

Label at a glance#

ProductBenadryl Allergy Extra Strength Liqui-Gels
Active ingredientDIPHENHYDRAMINE HCL
Label structure10 sections

Indications and 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 the common cold: runny nose sneezing

Dosage and administration

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 and over 1 capsule children under 12 years do not use

Storage and handling

store between 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. do not use if blister unit is torn or broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

​Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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 the common cold:

runny nose

sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE 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

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • avoid alcoholic drinks

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 and over1 capsule
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light.
  • do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

NDC 50580-322-20

Benadryl ®

ALLERGY ®

EXTRA STRENGHT

LIQUI GELS ®*

Diphenhydramine HCl 50 mg

Antihistamine

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

*liquid-filled capsules

Actual Size

20 CAPSULES

benadryl_1.jpgbenadryl_1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1050076Benadryl Allergy 50 MG Oral CapsulePSN3
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3
1050076diphenhydramine hydrochloride 50 MG Oral Capsule [Benadryl]SBD3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3
1050076Benadryl 50 MG Oral CapsuleSY3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450596208GTIN-13: 0300450596208
EAN-13: 0300450596208
GTIN-12: 300450596208
UPC-A: 300450596208
GTIN storage (14 digits): 00300450596208		benadryl_1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-322-20Benadryl Allergy Extra Strength Liqui-Gels2 in 1 CARTONCAPSULE, LIQUID FILLED23
50580-322-20Benadryl Allergy Extra Strength Liqui-Gels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-32250580-322-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HCLTC2D6JAD40ACTIB
GLYCERINPDC6A3C0OXIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benadryl Allergy Extra Strength Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC30aca3ab-b091-3939-e063-6294a90a98192025-12-03WarningsExact identifier
ndc (package): 50580-322-20
ndc (product): 50580-322
ndc11 (package): 50580032220
spl id: 451a21a1-4357-d575-e063-6394a90a900a
spl set id: 30aca3ab-b091-3939-e063-6294a90a9819

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.