FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Precision Dose, Inc.
Effective date
2025-09-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:48

Label at a glance#

ProductDiphenhydramine Hydrochloride
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 nose temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

Use as directed per healthcare professional. take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and older 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 20 mg store at 20-25°C (68-77°F). Avoid high humidity. Protect from light small tablet size, easy to swallow

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

25 mg Tablets

For Hospital Use Only

LI1729 Rev. 10/24

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine 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 nose
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

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

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

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use as directed per healthcare professional.
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
adults and children 12 years and older1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg
  • store at 20-25°C (68-77°F).
  • Avoid high humidity. Protect from light
  • small tablet size, easy to swallow

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-397-9228

SPL UNCLASSIFIED SECTION

Gluten Free

How Supplied

HOW SUPPLIED SECTION

They are supplied as follows:
NDC 68094-018-61
Unit Dose Packages of 100 Tablets (10×10) per Carton

SPL UNCLASSIFIED SECTION

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1729 Rev. 10/24

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrecisionDose™

NDC 68094-018-61
Unit Dose

diphenhydrAMINE HCl
25 mg Tablets
100 Tablets
(10x10)

Each tablet contains:
Diphenhydramine Hydrochloride 25 mg
Calcium 20 mg

Gluten Free

USUAL DOSE: SEE ENCLOSED DRUG FACTS.

Store at 20-25°C (68-77°F).
Avoid high humidity. Protect from light.

Keep out of reach of children.
Hospital Use Only.

LC1733
R0

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD5

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
68094-018-59Diphenhydramine Hydrochloride10 in 1 BLISTER PACKTABLET105
68094-018-61Diphenhydramine Hydrochloride10 in 1 CARTONTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-018-59EA - Each68094-01864535cc0-28a9-4b6d-baa9-5b6541cc7fa512019-08-06
68094-018-61EA - Each68094-01876194eaa-6c1c-4f96-b3c0-3cdd75a2876412019-08-06
0113-0479-53EA - Each0113-0479ee7a9bd6-c9e5-4049-a57f-f0df7b23a1c912018-02-20
0113-0479-62EA - Each0113-04798f6a54c4-4fa6-4bf7-a24a-10810f8a4ac412013-02-13
0113-0479-78EA - Each0113-0479d935c09b-7aa6-4a73-a496-1316061e792112013-02-13
0113-0479-79EA - Each0113-04794a7a8732-c938-489c-a655-e838ed92030012020-09-14

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
68094-01868094-018-59, 68094-018-61
0113-0479

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
diphenhydramine hydrochlorideTC2D6JAD40ACTIB
carnauba waxR12CBM0EIZIACT
crospovidone (120 .MU.M)68401960MKIACT
D&C Red No. 272LRS185U6KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Polysorbate 806OZP39ZG8HIACT
STEARIC ACID4ELV7Z65APIACT
Titanium dioxide15FIX9V2JPIACT
anhydrous dibasic calcium phosphateL11K75P92JIACT

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 HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPrecision Dose, Inc.4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea42025-09-12WarningsExact identifier
ndc (package): 68094-018-59
ndc (package): 68094-018-61
ndc (product): 68094-018
ndc11 (package): 68094001861
ndc11 (package): 68094001859
spl id: 315b150d-b34d-422c-b3c4-287dd908df8f
spl set id: 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4
good sense allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Company2cfa69b4-e33f-442a-a6df-b021b041da142024-02-01WarningsExact identifier
ndc (product): 0113-0479

Reported adverse events (FAERS/openFDA)#

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