FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
CVS Pharmacy, Inc
Effective date
2024-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:37

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each mini-capsule)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged 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 breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

  • store in a dry place at 15° – 30°C (59° – 86°F)
  • use by expiration date on package
  • protect from moisture

INACTIVE INGREDIENT SECTION

anhydrous citric acid, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose monohydrate, magnesium stearate, polysorbate 80, potassium sorbate, sodium lauryl sulfate, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
V-34571

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks Unisom® and SleepMinis®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Unisom® SleepMinis®*

Nighttime
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid
Non-habit forming

120 MINI-CAPSULES

CVS LabelCVS Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
51316-347-05Diphenhydramine Hydrochloride120 in 1 BOTTLECAPSULE1202
51316-347-05Diphenhydramine Hydrochloride1 in 1 CARTONCAPSULE12
51316-347-06Diphenhydramine Hydrochloride365 in 1 BOTTLECAPSULE3652

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-347DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CVS PHARMACY, INC]2Current NDC, 3 package rows20240214_f5b609e1-e63b-2e3b-e053-2995a90a76b9.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-34751316-347-05, 51316-347-06

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
FD&C BLUE NO. 1H3R47K3TBDIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
GELATIN2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STARCH, CORNO8232NY3SJIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SODIUM LAURYL SULFATE368GB5141JIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYSORBATE 806OZP39ZG8HIACT

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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf5b609e1-e63b-2e3b-e053-2995a90a76b92024-02-12WarningsExact identifier
ndc (package): 51316-347-06
ndc (package): 51316-347-05
ndc (product): 51316-347
ndc11 (package): 51316034706
ndc11 (package): 51316034705
spl id: 1135711a-2949-da66-e063-6394a90ad4f0
spl set id: f5b609e1-e63b-2e3b-e053-2995a90a76b9

Reported adverse events (FAERS/openFDA)#

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