FDA.reportPublic FDA data

Quality Choice Nighttime Sleep-Aid

Manufacturer
Chain Drug Marketing Association, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:15

Label at a glance#

ProductQuality Choice Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

•for relief of occasional sleeplessness •reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

•take only one dose per day (24 hours)  adults and children  12 years and over  take 2 softgels at bedtime if needed  or as directed by a doctor  children under 12 years  do not use

Storage and handling

•store at 20-25°C (68-77°F) •avoid excessive heat above 40°C (104°F)  •protect from light  

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

•for relief of occasional sleeplessness
•reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use  •for children under 12 years of age  •with any other product containing diphenhydramine, even one used on skin  •with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have  •glaucoma  •heart diseases  •a breathing problem such as emphysema, asthma, or chronic bronchitis  •difficulty in urination due to enlargement of the prostate gland

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

When using this product  •avoid alcoholic beverages and other drugs that cause drowsiness.  •be careful when driving a motor vehicle or operating machinery.

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.

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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

•take only one dose per day (24 hours)

 adults and children
 12 years and over		 take 2 softgels at bedtime if needed
 or as directed by a doctor
 children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

•store at 20-25°C (68-77°F)
•avoid excessive heat above 40°C (104°F)  •protect from light  

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue#1, FD&C red#40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

*Compare to active ingredient in VICKS® ZzzQUIL™ Liquicaps™

Non-habit Forming
Fall Asleep Fast

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by The Proctor & Gamble Company. ZzzQUIL™ is the registered trademark of The Proctor and Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Product of UAE
Packaged and Quality Assured in the USA

REV.01-092022

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality-970Quality-970

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

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
63868-970-24Quality Choice Nighttime Sleep-Aid2 in 1 CARTONCAPSULE, LIQUID FILLED24
63868-970-24Quality Choice Nighttime Sleep-Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-970QUALITY CHOICE NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.]4Current NDC, 2 package rows20250101_e8b2858b-a737-c500-e053-2995a90adba6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-97063868-970-24

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
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
Quality Choice Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association, Inc.e8b2858b-a737-c500-e053-2995a90adba62024-12-16WarningsExact identifier
ndc (package): 63868-970-24
ndc (product): 63868-970
ndc11 (package): 63868097024
spl id: 5ce01eb6-2e0d-4c50-9059-61f5f2a009dd
spl set id: e8b2858b-a737-c500-e053-2995a90adba6

Reported adverse events (FAERS/openFDA)#

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