FDA.reportPublic FDA data

Benadryl

Manufacturer
Kenvue Brands LLC
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:57:02

Label at a glance#

ProductBenadryl Allergy Liqui-Gels
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
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 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 in children under 6 years of age

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness 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, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • 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 in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

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

NDC 50580-228-24

Benadryl®

ALLERGY

LIQUI GELS ®*

Diphenhydramine HCl 25 mg | Antihistamine

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat

DYE-FREE

*liquid-filled capsules

Actual Size

24 CAPSULES

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049910Benadryl Allergy Liqui-Gel 25 MG Oral CapsulePSN10
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN10
1049910diphenhydramine hydrochloride 25 MG Oral Capsule [Benadryl]SBD10
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD10
1049910Benadryl 25 MG Oral CapsuleSY10
1049910Benadryl Dye-Free Allergy 25 MG Oral CapsuleSY10

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-130312547170215GTIN-13: 0312547170215
EAN-13: 0312547170215
GTIN-12: 312547170215
UPC-A: 312547170215
GTIN storage (14 digits): 00312547170215		benadryl-01.jpg
Data codeCode 12830035351benadryl-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-228-242024-02-01C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®
50580-228-482024-02-01C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®
50580-228-492024-02-01C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®
50580-228-242024-01-30C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®
50580-228-482024-01-30C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®
50580-228-492024-01-30C16284748780-11030e365-13ea-111a-e063-dadaa90a10e2Benadryl ® Allergy Liqui-Gels ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-228-24Benadryl Allergy Liqui-Gels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-228-24Benadryl Allergy Liqui-Gels2 in 1 CARTONCAPSULE, LIQUID FILLED210
50580-228-48Benadryl Allergy Liqui-Gels2 in 1 PACKAGECAPSULE, LIQUID FILLED210
50580-228-48Benadryl Allergy Liqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED410
50580-228-49Benadryl Allergy Liqui-Gels4 in 1 CARTONCAPSULE, LIQUID FILLED410
50580-228-49Benadryl Allergy Liqui-Gels3 in 1 PACKAGECAPSULE, LIQUID FILLED310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-228-24EA - Each50580-22800a84415-c75c-4e95-872c-4e52da22ede112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD402
diphenhydramineACTIVE MOIETY8GTS82S83M2
gelatinINACTIVE INGREDIENT2G86QN327L2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A2
sorbitolINACTIVE INGREDIENT506T60A25R2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-22850580-228-24, 50580-228-48, 50580-228-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
72 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
72 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
72 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
72 equally ranked IID candidates

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 Liqui-GelsDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCbfeae100-e2d1-4607-be3b-2d9b15cd4f7f2026-05-07WarningsExact identifier
ndc (package): 50580-228-24
ndc (package): 50580-228-48
ndc (package): 50580-228-49
ndc (product): 50580-228
ndc11 (package): 50580022848
ndc11 (package): 50580022824
ndc11 (package): 50580022849
spl id: 51352d7f-3c17-f0da-e063-6394a90a6be4
spl set id: bfeae100-e2d1-4607-be3b-2d9b15cd4f7f

Reported adverse events (FAERS/openFDA)#

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