FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Chain Drug Marketing Association
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:24:33

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 exceed 6 doses in 24 hours adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules) children 6 to under 12 years of age 12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. to 25 mg (1 capsule) children under 6 years of age ask a doctor

Storage and handling

store at room temperature 15°-30°C (59°-86°F) protect from moisture retain carton for complete product information

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

OTC - DO NOT USE SECTION

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours
adults and children 12 years of age and over25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age12.5 mg * to 25 mg (1 capsule)
children under 6 years of ageask a doctor

* 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63868-087-24

QUALITY CHOICE

†Compare to BENADRYL® Allergy Kapseals active ingredient

Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Capsules

24 count24 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3

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
63868-087-01Allergy Relief1 in 1 CARTONCAPSULE13
63868-087-01Allergy Relief100 in 1 BOTTLE, PLASTICCAPSULE1003
63868-087-24Allergy Relief2 in 1 CARTONCAPSULE23
63868-087-24Allergy Relief12 in 1 BLISTER PACKCAPSULE123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-087ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 4 package rows20241013_8eab9d79-69c1-44b8-9145-a7ebd887d54d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-087-01EA - Each63868-087210f3930-c05e-4412-b846-a3295d8e6cca12014-11-05
63868-087-24EA - Each63868-0878c6d0eff-aac3-46d1-9b21-30275779606412014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-08763868-087-24, 63868-087-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 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
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association8eab9d79-69c1-44b8-9145-a7ebd887d54d2024-10-11WarningsExact identifier
ndc (package): 63868-087-24
ndc (package): 63868-087-01
ndc (product): 63868-087
ndc11 (package): 63868008724
ndc11 (package): 63868008701
spl id: 24357076-8e9f-69bc-e063-6394a90af9c8
spl set id: 8eab9d79-69c1-44b8-9145-a7ebd887d54d

Reported adverse events (FAERS/openFDA)#

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