FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Capsules USP, 25 mg

Manufacturer
Elysium Pharmaceuticals Limited
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:53:10

Label at a glance#

ProductDiphenhydramine Hydrochloride 25
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

diphenydramine HCL 25mg 

OTC - PURPOSE SECTION

antihistaminc and for further packing and labelling 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach children 

WARNINGS SECTION

for further packing and labelling 

INACTIVE INGREDIENT SECTION

Allura Red AC IH, Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Polyethylene Glycol 400 - India glycols USP/NF,,Purified water, Sorbitol solution 70% Non crystalline,Medium chain triglycerides,white ink.

INDICATIONS & USAGE SECTION

antihstaminc and for further final packing 

DOSAGE & ADMINISTRATION SECTION

antihsitaminc and for further packing 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelbulk label

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 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14803-91214803-912-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
SORBITOL SOLUTION8KW3E207O2IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
48ce63d7-e2c5-b448-e063-6294a90a2e943d55914e-0769-2282-e063-6394a90a3a482026-01-19WarningsExact identifier
spl id: 48ce63d7-e2c5-b448-e063-6294a90a2e94
spl set id: 3d55914e-0769-2282-e063-6394a90a3a48

Reported adverse events (FAERS/openFDA)#

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