Benadryl

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-11-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:38:47

Label at a glance#

ProductBenadryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 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 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

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

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, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Repackaged and distributed by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

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

ULTRATABS ®*

*small tablet size

6
Tablets

3 POUCHES OF 2 TABLETS EACH

Lil'

Drug Store ®

Principal Display Panel - 25 mg Tablet Pouch CartonPrincipal Display Panel - 25 mg Tablet Pouch Carton

Benadryl ® Allergy, 4ct - Travel BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg| Antihistamine

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

ULTRATABS ®*

*small tablet size

4 Tablets

2 POUCHES OF 2 TABLETS EACH

[Travel BASIX logo]

PDP/PackagePDP/Package

Benadryl ® Allergy, 4ct - CVP ® HEALTH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

ULTRATABS ®*
*small tablet size

4
Tablets
2 POUCHES OF 2 TABLETS EACH

[CVP HEALTH logo]

PDP/PackagePDP/Package

Benadryl ® Allergy, 25pc - Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing

Runny Nose
Itchy, Watery Eyes

Itchy Throat

ULTRATABS ®*
*small tablet size

[tablet image]

25 POUCHES OF
2 TABLETS EACH

[Lil Drug Store logo]

PDP/PackagePDP/Package

Benadryl ® Allergy, 30pc - Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benadryl

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing

Runny Nose
Itchy, Watery Eyes

Itchy Throat

ULTRATABS®*
*small tablet size

[tablet image]

25 POUCHES OF
2 TABLETS EACH

[Lil Drug Store logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049632Benadryl 25 MG Oral TabletPSN10
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN10
1049632diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl]SBD10
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD10
1049632Benadryl 25 MG Oral TabletSY10
1049632Benadryl Allergy Ultratab 25 MG Oral TabletSY10

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6406-2Benadryl2 in 1 CARTONTABLET, FILM COATED210
66715-6406-2Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-6406-7Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-6406-7Benadryl25 in 1 BOX, UNIT-DOSETABLET, FILM COATED2510
66715-6406-8Benadryl30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3010
66715-6406-8Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-6506-2Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-6506-2Benadryl2 in 1 CARTONTABLET, FILM COATED210
66715-9706-1Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-9706-1Benadryl1 in 1 CARTONTABLET, FILM COATED110
66715-9706-2Benadryl2 in 1 CARTONTABLET, FILM COATED210
66715-9706-2Benadryl2 in 1 POUCHTABLET, FILM COATED210
66715-9706-3Benadryl3 in 1 CARTONTABLET, FILM COATED310
66715-9706-3Benadryl2 in 1 POUCHTABLET, FILM COATED210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6406BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, 6 package rows20241123_de2a64ce-c169-4162-b79e-d3809bea2147.zip
66715-6506BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, 2 package rows20241123_de2a64ce-c169-4162-b79e-d3809bea2147.zip
66715-9706BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 6 package rows20241123_de2a64ce-c169-4162-b79e-d3809bea2147.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD402
DiphenhydramineACTIVE MOIETY8GTS82S83M2
aluminum oxideINACTIVE INGREDIENTLMI26O69332
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEP2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZ2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
crospovidoneINACTIVE INGREDIENT68401960MK2
D&C red no. 27INACTIVE INGREDIENT2LRS185U6K2
hypromellosesINACTIVE INGREDIENT3NXW29V3WO2
magnesium stearateINACTIVE INGREDIENT70097M6I302
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H2
stearic acidINACTIVE INGREDIENT4ELV7Z65AP2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92023-09-26full-release2026-05-31 23:56:21

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 3 · 130 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
calcium phosphate, dibasic, dihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
carnauba waxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
D&C red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
40 equally ranked IID candidates
polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
10 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
BenadrylDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.de2a64ce-c169-4162-b79e-d3809bea21472024-11-22WarningsExact identifier
ndc (package): 66715-6406-8
ndc (package): 66715-6506-2
ndc (package): 66715-9706-3
ndc (package): 66715-9706-2
ndc (package): 66715-6406-2
ndc (package): 66715-6406-7
ndc (package): 66715-9706-1
ndc (product): 66715-6406
ndc (product): 66715-6506
ndc (product): 66715-9706
ndc11 (package): 66715640608
ndc11 (package): 66715640607
ndc11 (package): 66715650602
ndc11 (package): 66715970602
ndc11 (package): 66715970603
ndc11 (package): 66715970601
ndc11 (package): 66715640602
spl id: 2783d396-2842-91e9-e063-6294a90a88fe
spl set id: de2a64ce-c169-4162-b79e-d3809bea2147

Reported adverse events (FAERS/openFDA)#

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