FDA.reportPublic FDA data

Somnapure

Manufacturer
NutraClick, LLC | LNK International, Inc.
Effective date
2018-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:03

Label at a glance#

ProductSomnapure Clinical Strength
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

OTC - PURPOSE SECTION

Purpose

Nighttime sleep aid

INDICATIONS & USAGE SECTION

Use for relief of occasional sleeplessness

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have 

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you are taking sedatives, tranquilizers, or any other sleep aid. 

OTC - WHEN USING SECTION

When using this product, avoid alcoholic drinks. 

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.  Insomnia may be a symptom of a serious underlying medical illness. 

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, 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. 

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older: 1 caplet (50 mg) at bedtime if needed, or as directed by a doctor

OTHER SAFETY INFORMATION

Other information 

  • each caplet contains: calcium 50 mg
  • store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesiu stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide 

OTC - QUESTIONS SECTION

Questions of comments?  Call 1-855-606-6507

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Peak Life Somnapure 

Clinical Strength 

Nighttime Sleep Aid / Diphenhydramine HCl 

#1 Doctor-Recommended Ingredient

  • Fall Asleep Quickly
  • Wake Up Energized
  • Non-Habit-Forming

30 Sleep Caplets 

One Caplet per Dose

LNK Carton

LNK CartonLNK Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSN1
1609070Somnapure Clinical Strength 50 MG Oral TabletPSN1
1609070diphenhydramine hydrochloride 50 MG Oral Tablet [Somnapure]SBD1
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCD1
1609070Somnapure 50 MG Oral TabletSY1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69721-003-302020-01-31C16284748780-19d75b9d0-aa89-f424-e053-dadaa90a57ceSomnapure Clinical Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69721-003-30SomnapureClinical Strength30 in 1 BOTTLETABLET, COATED301
69721-003-30SomnapureClinical Strength1 in 1 BOXTABLET, COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69721-003SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC]1Legacy NDC, 2 package rows20180330_13e2660d-d0a2-4d57-b2de-4c41257ccf83.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69721-00369721-003-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
8d952168-b9dd-485e-9776-b4bb068bc02e13e2660d-d0a2-4d57-b2de-4c41257ccf832018-03-20WarningsExact identifier
spl id: 8d952168-b9dd-485e-9776-b4bb068bc02e
spl set id: 13e2660d-d0a2-4d57-b2de-4c41257ccf83

Reported adverse events (FAERS/openFDA)#

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