FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Elysium Pharmaceuticals Limited
Effective date
2026-02-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:34:07

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Antihstaminic product and for further packing 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE SECTION

Antihstaminic product

DOSAGE & ADMINISTRATION SECTION

for further packing only

WARNINGS SECTION

CAUTION : “FOR FURTHER, PROCESSING OR REPACKING”

INACTIVE INGREDIENT SECTION

Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Propylene glycol USP, Sorbitol/Sorbitan anhydrous (POLYSORB) USP/NF Polyethlylene gylcol,Purified water,Triglyceride medium chain

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14803-90314803-903-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
4a3b83e5-7850-f67c-e063-6394a90a20c2b50c1994-48f4-d011-e053-2995a90af9cf2026-02-07WarningsExact identifier
spl id: 4a3b83e5-7850-f67c-e063-6394a90a20c2
spl set id: b50c1994-48f4-d011-e053-2995a90af9cf

Reported adverse events (FAERS/openFDA)#

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