warnings
WARNINGS Do not use 25 MG to make a child sleepy with any other product containing diphenhydramine, even one used on skin 50 MG to make a child sleepy with any other product containing diphenhydramine, including one applied topically
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
- Major Pharmaceuticals
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 04e70311-6412-4a20-84e3-f6e26d5f19ab
- SPL ID
- 4b432cbb-d3d9-2f88-e063-6294a90a7ed5
- Version
- 17
- Effective date
- 2026-02-20
- Source export date
- 2026-10-27
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:59:03
| 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 | M012 | openfda.application_number | |
| brand name | Diphenhydramine Hydrochloride | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Major Pharmaceuticals | openfda.manufacturer_name | |
| ndc | package | 0904-5306-24 | openfda.package_ndc |
| ndc | package | 0904-5306-61 | openfda.package_ndc |
| ndc | package | 0904-5306-80 | openfda.package_ndc |
| ndc | package | 0904-2035-24 | openfda.package_ndc |
| ndc | package | 0904-5306-60 | openfda.package_ndc |
| ndc | package | 0904-2056-61 | openfda.package_ndc |
| ndc | product | 0904-2056 | openfda.product_ndc |
| ndc | product | 0904-5306 | openfda.product_ndc |
| ndc | product | 0904-2035 | openfda.product_ndc |
| ndc11 | package | 00904530661 | derived:openfda.package_ndc |
| ndc11 | package | 00904530660 | derived:openfda.package_ndc |
| ndc11 | package | 00904530624 | derived:openfda.package_ndc |
| ndc11 | package | 00904205661 | derived:openfda.package_ndc |
| ndc11 | package | 00904203524 | derived:openfda.package_ndc |
| ndc11 | package | 00904530680 | derived:openfda.package_ndc |
| rxcui | 1092422 | openfda.rxcui | |
| rxcui | 1049909 | openfda.rxcui | |
| rxcui | 1020477 | openfda.rxcui | |
| spl id | 4b432cbb-d3d9-2f88-e063-6294a90a7ed5 | id | |
| spl set id | 04e70311-6412-4a20-84e3-f6e26d5f19ab | 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.