FDA.reportPublic FDA data

PHARBEDRYL

Manufacturer
Ulai Health LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:17

Label at a glance#

ProductPHARBEDRYL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 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 common cold: runny nose sneezing

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not exceed 6 doses in 24 hours adults and children 12 years and over 1 capsule children under 12 years ask a doctor

Storage and handling

store at 20-25 o C (68-77 o F)

Label contents#

Full prescribing information#

Active ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50mg

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 common cold:
  • runny nose
  • sneezing

Do not use

OTC - DO NOT USE SECTION

  • 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

  • drowsiness may occur
  • avoid alcoholic drinks

  • alcohol, sedatives & tranquilizers may increase drowsiness

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

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not exceed 6 doses in 24 hours

adults and children 12 years and over

1 capsule

children under 12 years

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25 oC (68-77 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50 mg

Antihistamine

•Sneezing                   •Runny Nose

•Itchy, Watery Eyes     •Itchy Throat

1000 CAPSULES

Ulai Pharbedryl 50mg Capsule 1000ct Capsule LabelUlai Pharbedryl 50mg Capsule 1000ct Capsule Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3

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
73057-347-082022-01-31C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-112022-01-31C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-082022-01-28C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts
73057-347-112022-01-28C16284748780-1d6a99b39-6abd-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-347-08PHARBEDRYL100 in 1 BOTTLE, PLASTICCAPSULE1003
73057-347-11PHARBEDRYL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-347PHARBEDRYL (DIPHENHYDRAMINE HCL 50MG) CAPSULE [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250122_135293fb-5674-4638-be55-b968cf51257e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73057-34773057-347-11, 73057-347-08

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
FERROSOFERRIC OXIDEXM0M87F357IACT
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

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
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
ndc (package): 73057-347-08
ndc (package): 73057-347-11
ndc (product): 73057-347
ndc11 (package): 73057034711
ndc11 (package): 73057034708
spl id: 2c2777c1-a456-d152-e063-6294a90a7539
spl set id: 135293fb-5674-4638-be55-b968cf51257e

Reported adverse events (FAERS/openFDA)#

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