FDA.reportPublic FDA data

Diphenhydramine HCL

Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2022-08-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:50:33

Label at a glance#

ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes.

Dosage and administration

Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule                                      Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor

Storage and handling

Store at room temperature 15-30  degrees C (59-86 degrees F) Protect from excessive moisture

Label contents#

Full prescribing information#

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 associated with the common cold, hay fever, or other respiratory allergies.
  • Sneezing.
  • Nasal congestion.
  • Runny nose.
  • Itchy, watery eyes.

Do not use

OTC - DO NOT USE SECTION

  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

If you have

  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • If you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • Avoid alcoholic drinks.
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children.
  • Alcohol, sedatives and tranquilizers may increase drowsiness.
  • Be careful when driving a motor vehicle or operating machinery.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 to 2 capsule                                     
Children 6 to under 12 years
1 capsule
Children under 6 years
ask a doctor

Other information:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-080-152025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-202025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-242025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-302025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-602025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts
66267-080-902025-01-30C16284748780-12cef2736-a88f-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-080-15Diphenhydramine HCL15 in 1 BOTTLE, PLASTICCAPSULE155
66267-080-20Diphenhydramine HCL20 in 1 BOTTLE, PLASTICCAPSULE205
66267-080-24Diphenhydramine HCL24 in 1 BOTTLE, PLASTICCAPSULE245
66267-080-30Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE305
66267-080-60Diphenhydramine HCL60 in 1 BOTTLE, PLASTICCAPSULE605
66267-080-90Diphenhydramine HCL90 in 1 BOTTLE, PLASTICCAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-080DIPHENHYDRAMINE HCL CAPSULE [NUCARE PHARMACEUTICALS, INC.]5Legacy NDC, 6 package rows20220831_3dbdf67f-766b-12ee-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-080-15EA - Each66267-0808e70239c-bd12-412b-95d5-3b52430e878f12016-10-06
66267-080-20EA - Each66267-08007bdd1aa-f4ce-4065-93e2-33a7106edff412016-10-06
66267-080-30EA - Each66267-080a745398b-7212-4a02-887a-a7abfd43b64f12016-10-06
66267-080-60EA - Each66267-08062c9460b-d856-4ddf-8be7-0b8a279afa3212016-10-06
66424-020-01EA - Each66424-02062be7459-d627-4d56-af74-b18dfb1581dc12012-07-24
66424-020-10EA - Each66424-020cc145bd4-6e21-4bfe-a7b2-2ffe0528742b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66267-08066267-080-15, 66267-080-20, 66267-080-30, 66267-080-60, 66267-080-90, 66267-080-24
66424-020

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
ndc (product): 66424-020
e767c105-d9e1-7162-e053-2a95a90afc9d3dbdf67f-766b-12ee-e054-00144ff8d46c2022-08-29WarningsExact identifier
spl id: e767c105-d9e1-7162-e053-2a95a90afc9d
spl set id: 3dbdf67f-766b-12ee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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