FDA.reportPublic FDA data

Nightime Sleep Aid

Manufacturer
Agile Pharmachem
Effective date
2018-05-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:37

Label at a glance#

ProductNightime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For relief of occasional sleeplessness.

Dosage and administration

adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor. children under 12 years: do not use

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional sleeplessness.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
  • children under 12 years:do not use

Warnings

WARNINGS SECTION

Do not use

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

    Ask a doctor before use if you have

  • 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 taking sedatives or tranquilizers

    When using this product

  • avoid alcoholic drinks

    If pregnant or breast-feeding, 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. (1-800-222-1222)

Other Information

SPL UNCLASSIFIED SECTION

  • save carton for full directions and warnings

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7898db8a-figure-01
7898db8a-figure-01

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-02 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58805-006-022020-01-31C16284748780-19d75b9d0-d5be-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 50mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58805-006-02Nightime Sleep Aid750 in 1 BAGCAPSULE, LIQUID FILLED7502
58805-006-02Nightime Sleep Aid48 in 1 BOXCAPSULE, LIQUID FILLED482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58805-006NIGHTIME SLEEP AID (DIPHENHYDRAMINE) CAPSULE, LIQUID FILLED [AGILE PHARMACHEM]2Legacy NDC, 2 package rows20180521_3f12bd24-8265-44a0-9112-92c026c8e2fa.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58805-00658805-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
SORBITOL506T60A25RIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML · Source PDF

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
6cbc5356-76b4-5cc9-e053-2991aa0adfc83f12bd24-8265-44a0-9112-92c026c8e2fa2018-05-21WarningsExact identifier
spl id: 6cbc5356-76b4-5cc9-e053-2991aa0adfc8
spl set id: 3f12bd24-8265-44a0-9112-92c026c8e2fa

Reported adverse events (FAERS/openFDA)#

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