warnings
Warnings Do not use to make child sleepy with any other product containing diphenhydramine, even one used on skin
Diphenhydramine HCl
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 HCl
- Generic name
- DIPHENHYDRAMINE HCL
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 1ee41c86-6767-43ca-a5bb-fc685fa662cd
- SPL ID
- 30c8d0aa-5859-b584-e063-6394a90ac88e
- Version
- 13
- Effective date
- 2025-03-20
- Source export date
- 2026-11-06
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:52:11
| 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 HCl | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HCL | openfda.generic_name | |
| manufacturer name | PD-Rx Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 55289-479-20 | openfda.package_ndc |
| ndc | package | 55289-479-30 | openfda.package_ndc |
| ndc | package | 55289-479-15 | openfda.package_ndc |
| ndc | package | 55289-479-24 | openfda.package_ndc |
| ndc | package | 55289-479-10 | openfda.package_ndc |
| ndc | package | 55289-479-12 | openfda.package_ndc |
| ndc | product | 55289-479 | openfda.product_ndc |
| ndc11 | package | 55289047912 | derived:openfda.package_ndc |
| ndc11 | package | 55289047920 | derived:openfda.package_ndc |
| ndc11 | package | 55289047924 | derived:openfda.package_ndc |
| ndc11 | package | 55289047910 | derived:openfda.package_ndc |
| ndc11 | package | 55289047915 | derived:openfda.package_ndc |
| ndc11 | package | 55289047930 | derived:openfda.package_ndc |
| rxcui | 1049909 | openfda.rxcui | |
| spl id | 30c8d0aa-5859-b584-e063-6394a90ac88e | id | |
| spl set id | 1ee41c86-6767-43ca-a5bb-fc685fa662cd | 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.