FDA.reportPublic FDA data

M-Dryl

Manufacturer
Bryant Ranch Prepack
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
104
Source
full-release
Hydrated at
2026-06-01 00:39:37

Label at a glance#

ProductM-Dryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

Dosage and administration

take every 4 to 6 hours use an accurate measuring device to administer this Medication children under 2 years do not use do not use children 2 to 5 years ask a doctor children 6 years to under 12 years 5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours adults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

Storage and handling

each tsp contains: sodium 5 mg store at 15° to 30°C (59° to 86°F)  protect from freezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

M-Dryl

Diphenhydramine HydrochlorideOral Solution

Antihistamine

Cherry Flavor

RELIEVES

  • Sneezing
  • Itchy, Watery Eyes
  • Runny Nose
  • Itchy Throat due to Allergies

DO NOT USE IF TAMPER EVIDENT SEAL

UNDER CAP IS BROKEN OR MISSING

Alcohol Free

Each 5 mL (1 teaspoonful) contains:

Diphenhydramine HCl ................ 12.5 mg

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL = 1 tsp)

Diphenhydramine HCl ..................................................... 12.5 mg

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

  • 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

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

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

  • 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

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 to 6 hours
  • use an accurate measuring device to administer this Medication
children under 2 years do not usedo not use
children 2 to 5 yearsask a doctor
children 6 years to under 12 years5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours
adults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours

Other information

STORAGE AND HANDLING SECTION

  • each tsp contains: sodium 5 mg
  • store at 15° to 30°C (59° to 86°F) 

protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid Anhydrous, FD&C red No. 40, Glycerin, Masking Agent, Propylene Glycol, Purified water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution.

Questions?

OTC - QUESTIONS SECTION

Serious side effects associated with use of this product may be reported to this number. Call 1-877-250-3427 Mon. - Fri. (8 a.m. to 5 p.m. CST).

HOW SUPPLIED

How Supplied Section

NDC 63629-1159-1: 120 mL in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M-Dryl Oral Liquid 12.5 mg/5 mL

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN104
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD104
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY104
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY104
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY104

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
63629-1159-1M-Dryl120 mL in 1 BOTTLELIQUID120104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1159M-DRYL (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241128_9cd10af6-a2fa-44f8-8df3-a6d2a95a5293.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1159-1ML - Milliliter63629-11594e803cb1-80b1-41b4-8a09-be351637621612021-01-08
58657-528-04ML - Milliliter58657-528265ac152-5371-4230-857a-ac050c9efddf12019-09-05
58657-528-16ML - Milliliter58657-5287692d868-6561-46ac-8d17-ec2a9710c2c612019-09-05

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
63629-115963629-1159-1
58657-528

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

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
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEMethod Pharmaceuticals, LLC5a60c923-8bb7-427f-9636-08ed5474f71b2025-10-21WarningsExact identifier
ndc (product): 58657-528
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepack9cd10af6-a2fa-44f8-8df3-a6d2a95a52932024-11-27WarningsExact identifier
ndc (package): 63629-1159-1
ndc (product): 63629-1159
ndc11 (package): 63629115901
spl id: 85072cf1-c6f4-4fa7-b53b-7a5056f39aa0
spl set id: 9cd10af6-a2fa-44f8-8df3-a6d2a95a5293

Reported adverse events (FAERS/openFDA)#

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