warnings
Warnings Do not use with any other product containing diphenhydramine, even one use on skin to make a child sleepy
Diphenhydramine HCL 25 mg
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 25 mg
- Generic name
- DIPHENHYDRAMINE HCL
- Manufacturer
- Reliable 1 Laboratories LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 32f58cb3-941f-263b-e054-00144ff8d46c
- SPL ID
- 2bc8473d-acff-da1d-e063-6394a90ae0d4
- Version
- 7
- Effective date
- 2025-01-15
- Source export date
- 2026-09-28
- 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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:12:41
| 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 HCL 25 mg | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HCL | openfda.generic_name | |
| manufacturer name | Reliable 1 Laboratories LLC | openfda.manufacturer_name | |
| ndc | package | 69618-025-01 | openfda.package_ndc |
| ndc | product | 69618-025 | openfda.product_ndc |
| ndc11 | package | 69618002501 | derived:openfda.package_ndc |
| rxcui | 1049630 | openfda.rxcui | |
| spl id | 2bc8473d-acff-da1d-e063-6394a90ae0d4 | id | |
| spl set id | 32f58cb3-941f-263b-e054-00144ff8d46c | 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.