warnings
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin
Diphenhydramine hydrochloride
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Diphenhydramine hydrochloride
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 32033991-a4f0-f767-e063-6394a90a0b06
- SPL ID
- 47db0e8e-5351-a9ae-e063-6394a90aba50
- Version
- 3
- Effective date
- 2026-01-27
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:00
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M010 | openfda.application_number | |
| brand name | Diphenhydramine hydrochloride | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Softgel Healthcare Pvt Ltd | openfda.manufacturer_name | |
| ndc | package | 35916-0472-3 | openfda.package_ndc |
| ndc | package | 35916-0472-2 | openfda.package_ndc |
| ndc | package | 35916-0472-1 | openfda.package_ndc |
| ndc | product | 35916-0472 | openfda.product_ndc |
| ndc11 | package | 35916047201 | derived:openfda.package_ndc |
| ndc11 | package | 35916047203 | derived:openfda.package_ndc |
| ndc11 | package | 35916047202 | derived:openfda.package_ndc |
| rxcui | 1020477 | openfda.rxcui | |
| spl id | 47db0e8e-5351-a9ae-e063-6394a90aba50 | id | |
| spl set id | 32033991-a4f0-f767-e063-6394a90a0b06 | set_id | |
| unii | TC2D6JAD40 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.