FDA.reportPublic FDA data

Somnapure

Manufacturer
Force Factor Brands LLC
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:18

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 

helps to reduce difficulty in falling asleep

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 or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product, avoid alcoholic beverages. 

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 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 (1-800-222-1222)  right away. 

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor
  • Children under 12 years: do not use.

OTHER SAFETY INFORMATION

Other information 

  • each caplet contains: calcium 50 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number.
  • protect from moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium 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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Force Factor Somnapure

Clinical Strength

Nighttime Sleep Aid / Diphenhydramine HCl

#1 Doctor-Recommended Ingredient

Fall Asleep Quickly
Wake Up Energized
Non-Habit-Forming

30 Caplets

One Caplet per Dose

labellabel

boxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSN4
1609070Somnapure Clinical Strength 50 MG Oral TabletPSN4
1609070diphenhydramine hydrochloride 50 MG Oral Tablet [Somnapure]SBD4
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCD4
1609070Somnapure 50 MG Oral TabletSY4

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
69721-005-302022-02-01C16284748780-1d6a99b39-9a41-a426-e053-dadaa90af4c2Somnapure Clinical Strength
69721-005-302022-01-28C16284748780-1d6a99b39-9a41-a426-e053-dadaa90af4c2Somnapure Clinical Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69721-005-30SomnapureClinical Strength1 in 1 CARTONTABLET, COATED14
69721-005-30SomnapureClinical Strength30 in 1 BOTTLETABLET, COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69721-005SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FORCE FACTOR BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241210_063517c0-bcb1-46dd-85f1-bbb2f24274ef.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
69721-00569721-005-30

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. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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
Somnapure Clinical StrengthDIPHENHYDRAMINE HYDROCHLORIDEForce Factor Brands LLC063517c0-bcb1-46dd-85f1-bbb2f24274ef2024-12-06WarningsExact identifier
ndc (package): 69721-005-30
ndc (product): 69721-005
ndc11 (package): 69721000530
spl id: 35de71a0-7e1c-45fb-97d1-ddf485df6e3c
spl set id: 063517c0-bcb1-46dd-85f1-bbb2f24274ef

Reported adverse events (FAERS/openFDA)#

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