FDA.reportPublic FDA data

PHARBEDRYL

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:27

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: sneezing itching of the nose or throat runny nose itchy, watery eyes Temporarily relieves these symptoms due to common cold: runny nose sneezing

Dosage and administration

take every 4-6 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 of age Ask a doctor

Storage and handling

store at 20°-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each 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:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • Temporarily relieves these symptoms due to common cold:
  • runny nose
  • sneezing

Warnings

WARNINGS 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

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

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

  • avoid alcoholic drinks
  • drowsiness may occur
  • excitability may occur, especially in children

  • alcohol, sedatives & tranquilizers may increase drowsiness

  • use caution 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4-6 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 of age

Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68-77°F)

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 16103-0347-11

Manufactured in the USA

PHARBEDRYL

Diphenhydramine HCl 50mg

Antihistamine

• Sneezing • Runny Nose

• Itchy, Watery Eyes • Itchy Throat

1000 CAPSULES

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDERN

Pharbedryl (Diphenhydramine HCl) 50 mg Capsule Product LabelPharbedryl (Diphenhydramine HCl) 50 mg Capsule Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY4

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-130016103347119GTIN-13: 0016103347119
EAN-13: 0016103347119
GTIN-12: 016103347119
UPC-A: 016103347119
GTIN storage (14 digits): 00016103347119		Pharbedryl (Diphenhydramine HCl) 50 mg Capsule Product Label.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
16103-347-082024-12-31C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts
16103-347-112024-12-31C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts
16103-347-082023-01-30C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts
16103-347-112023-01-30C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts
16103-347-112021-03-30C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts
16103-347-112020-01-31C16284748780-19d75b9d0-9826-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-347-08PHARBEDRYL100 in 1 BOTTLE, PLASTICCAPSULE1004
16103-347-11PHARBEDRYL1000 in 1 BOTTLE, PLASTICCAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-347-11EA - Each16103-3471c087d47-7f50-486d-9c6d-fc6ee3317b4912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GELATININACTIVE INGREDIENT2G86QN327L1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1

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
16103-34716103-347-11, 16103-347-08

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
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

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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 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
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 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
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 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
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 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
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 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
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 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
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 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
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 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
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 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
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 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
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 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

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 HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
ndc (package): 16103-347-08
ndc (package): 16103-347-11
ndc (product): 16103-347
ndc11 (package): 16103034708
ndc11 (package): 16103034711
spl id: 3070b1f8-b3c8-4522-8b0f-06cedafc97ed
spl set id: a19f1edc-d2cf-45fc-8233-d882441b0247

Reported adverse events (FAERS/openFDA)#

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