FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Capsules, USP 25 mg (Dye Free)

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:55:02

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use this product in children under 6 years of age

Storage and handling

store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride USP 25mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

Do not use

WARNINGS SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a Doctor before use if you have

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

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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. In case of overdose, get medical help or contact aPoison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo not use this product in children under 6 years of age

Other Information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN6
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD6

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0435-1DIPHENHYDRAMINE HYDROCHLORIDE3 in 1 CARTONCAPSULE, LIQUID FILLED36
35916-0435-3DIPHENHYDRAMINE HYDROCHLORIDE1000 in 1 BAGCAPSULE, LIQUID FILLED10006
35916-0435-4DIPHENHYDRAMINE HYDROCHLORIDE2 in 1 BOXCAPSULE, LIQUID FILLED26
35916-0435-4DIPHENHYDRAMINE HYDROCHLORIDE3000 in 1 POUCHCAPSULE, LIQUID FILLED30006
35916-0435-5DIPHENHYDRAMINE HYDROCHLORIDE1500 in 1 BAGCAPSULE, LIQUID FILLED15006
35916-0435-5DIPHENHYDRAMINE HYDROCHLORIDE2 in 1 BOXCAPSULE, LIQUID FILLED26

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-043535916-0435-1, 35916-0435-3, 35916-0435-4, 35916-0435-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-01-24monthly-update2026-06-03 17:53:09

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 HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
ndc (package): 35916-0435-1
ndc (package): 35916-0435-4
ndc (package): 35916-0435-3
ndc (package): 35916-0435-5
ndc (product): 35916-0435
ndc11 (package): 35916043503
ndc11 (package): 35916043501
ndc11 (package): 35916043505
ndc11 (package): 35916043504
spl id: 5003a7e3-9310-497a-e063-6394a90a31ea
spl set id: 0203d919-dc1f-cca0-e063-6394a90aa1aa

Reported adverse events (FAERS/openFDA)#

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