FDA.reportPublic FDA data

Calmco Sleep Aid Vial (LA)

Manufacturer
CalmCo LLC
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:38

Label at a glance#

ProductCalmco Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed follow the “Easy to Use” instructions on pouch Age Dose Adults and children 12 years and older take 2 vials at bedtime, if needed children under 12 years do not use

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredient (in each 10 mL vial)Purpose
Diphenhydramine HCl 25 mg...............Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • have trouble urinating due to an enlarged prostate gland
  • are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid consuming alcohol beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sleeplessness persists continuously for more than 2 weeks.Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • follow the “Easy to Use” instructions on pouch
AgeDose
Adults and children 12 years and oldertake 2 vials at bedtime, if needed
children under 12 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • each 10 mL vial contains: sodium 4 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch has been torn open or vial is punctured or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol

Questions or comments?

OTC - QUESTIONS SECTION

+1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLEEP AID PDPSLEEP AID PDP

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

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
73282-252573282-2525-1, 73282-2525-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XYLITOLVCQ006KQ1EIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-29full-release2026-06-01 01:30:10

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
Calmco Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC471d4c70-813a-19de-e063-6394a90aeb252026-03-31WarningsExact identifier
ndc (package): 73282-2525-2
ndc (package): 73282-2525-1
ndc (product): 73282-2525
ndc11 (package): 73282252501
ndc11 (package): 73282252502
spl id: 4e58cc8b-5c0c-8da6-e063-6394a90a13a0
spl set id: 471d4c70-813a-19de-e063-6394a90aeb25

Reported adverse events (FAERS/openFDA)#

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