FDA.reportPublic FDA data

DORMMY-LON

Manufacturer
Haendel Farma, S.A. de C.V.
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:37:44

Label at a glance#

ProductDORMMY-LON
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

Helps to reduce difficulty in falling sleep For the relief of occasional sleeplessness

Dosage and administration

Take only one dose per day (24 hours)  Adults and children 12 years & over  2 pills or as directed by a doctor  children under 12 years  Do not use 

Label contents#

Full prescribing information#

Active Ingredient (in each pill)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses:

INDICATIONS & USAGE SECTION

  • Helps to reduce difficulty in falling sleep
  • For the relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • Difficulty in urination due to an enlarged prostate gland

Do not use

OTC - DO NOT USE SECTION

  • For children under 12 years of age
  • With any other product containing diphehydramine

Ask a doctor or pharmacist before use it if you are

OTC - ASK DOCTOR SECTION

taking sedatives, tranquilizers or any other drugs

When using this product

OTC - WHEN USING SECTION

  • Avoid alcoholic beverages

Stop use and ask a doctor if 

OTC - STOP USE SECTION

sleeplessness persists continuosly for more than 2 weeks, In sommia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only one dose per day (24 hours)
 Adults and children 12 years & over 2 pills or as directed by a doctor
 children under 12 years Do not use 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose, P.V.P., Starch, Blue Color FD&C # 1, Microcrystalline Cellulose, Croscarmellose, Sodium, Magnesium Stearate

Other information

SPL UNCLASSIFIED SECTION

  • Store at 68° - 77 °F (20-25 °C)
  • Protect from light.
  • See printed for lot number and exp. date.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package0Outer Package0Inner Package0Inner Package0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130702240509076GTIN-13: 0702240509076
EAN-13: 0702240509076
GTIN-12: 702240509076
UPC-A: 702240509076
GTIN storage (14 digits): 00702240509076		Inner Package0.jpg, Outer Package0.jpg
QR code linkQR Codedrive.google.com/open?id=1om54RSYFgou0RQKqv8uOyzNzqhXZ3L0LOuter Package0.jpg

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
83164-000-012024-07-30C16284748780-11030e365-1b4b-111a-e063-dadaa90a10e2DORMMY-LON
83164-000-012024-01-30C16284748780-11030e365-1b4b-111a-e063-dadaa90a10e2DORMMY-LON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83164-000-01DORMMY-LON60 in 1 BOTTLETABLET603
83164-000-01DORMMY-LON1 in 1 BOXTABLET13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83164-00083164-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM9NEZ333N27IACT
MAGNESIUM STEARATE70097M6I30IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE029TFK992NIACT

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
DORMMY-LONDIPHENHYDRAMINE HYDROCHLORIDEHaendel Farma, S.A. de C.V.562db961-83cb-4b74-9f34-fecee2c1be172026-01-27WarningsExact identifier
ndc (package): 83164-000-01
ndc (product): 83164-000
ndc11 (package): 83164000001
spl id: 4960ab74-45e1-6df7-e063-6394a90ac2d9
spl set id: 562db961-83cb-4b74-9f34-fecee2c1be17

Reported adverse events (FAERS/openFDA)#

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