warnings
Warnings Do not use to make a child sleepy; Do not use 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
- Time-Cap Labs, Inc
- Product type
- HUMAN OTC DRUG
- SPL set ID
- ed899055-0cbb-45bd-92c8-cbef2fc7c361
- SPL ID
- 7d3b9a35-9e04-4289-e053-2a91aa0a5042
- Version
- 2
- Effective date
- 2018-12-17
- Source export date
- 2026-11-06
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:45:55
| 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 | part341 | openfda.application_number | |
| brand name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Time-Cap Labs, Inc | openfda.manufacturer_name | |
| ndc | package | 49483-329-00 | openfda.package_ndc |
| ndc | product | 49483-329 | openfda.product_ndc |
| ndc11 | package | 49483032900 | derived:openfda.package_ndc |
| rxcui | 1049630 | openfda.rxcui | |
| spl id | 7d3b9a35-9e04-4289-e053-2a91aa0a5042 | id | |
| spl set id | ed899055-0cbb-45bd-92c8-cbef2fc7c361 | set_id | |
| unii | TC2D6JAD40 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings table
<table border="0" width="100%"> <tbody> <tr> <td> <paragraph> Warnings</paragraph> <paragraph>Do not use to make a child sleepy; Do not use with any other product containing diphenhydramine even one used on skin. </paragraph> <paragraph/> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.