FDA.reportPublic FDA data

Sominex

Manufacturer
Navajo Manufacturing Company Inc. | Navajo Manufacturing Company Inc
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:39

Label at a glance#

ProductSominex
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

A dults and children 12 years and older : take 2 tablets at bedtime if needed, or as directed by your doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

helps reduce difficultly falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines

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

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 beverages
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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 accidental overdose get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: take 2 tablets at bedtime if needed, or as directed by your doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 12 mg
  • store at 20º- 25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, microcrystalline, croscarmellose sodium, FD&C blue no. 1, hypromellose, lactose monohydrate, light mineral oil, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin

Questions?

OTC - QUESTIONS SECTION

1-866-255-5202 weekdays or visit www.sominex.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SominexSominex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1086986Sominex 25 MG Oral TabletPSN2
1086986diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]SBD2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2
1086986Sominex 25 MG Oral TabletSY2

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
67751-221-01Sominex1 in 1 CARTONTABLET, FILM COATED12
67751-221-01Sominex8 in 1 BLISTER PACKTABLET, FILM COATED82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-221SOMINEX (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 2 package rows20241004_f70ce1a6-c334-025e-e053-6294a90ae53f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-22167751-221-01
63029-554

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
LIGHT MINERAL OILN6K5787QVPIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
ndc (product): 63029-554
SominexDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.f70ce1a6-c334-025e-e053-6294a90ae53f2024-10-03WarningsExact identifier
ndc (package): 67751-221-01
ndc (product): 67751-221
ndc11 (package): 67751022101
spl id: 2396151b-13a0-cc41-e063-6394a90aa45b
spl set id: f70ce1a6-c334-025e-e053-6294a90ae53f

Reported adverse events (FAERS/openFDA)#

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