warnings
Do not use: for children under 12 years of age with any other product containing diphenhydramine, even one used on skin.
SleepAid Softgels
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
- SleepAid Softgels
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer
- PIONEER LIFE SCIENCES, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa
- SPL ID
- 9a01f49e-a58c-4f33-8be5-2106487f6cb6
- Version
- 2
- Effective date
- 2025-12-29
- Source export date
- 2026-11-06
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:45:12
| 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 | SleepAid Softgels | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | PIONEER LIFE SCIENCES, LLC | openfda.manufacturer_name | |
| ndc | package | 72090-023-01 | openfda.package_ndc |
| ndc | product | 72090-023 | openfda.product_ndc |
| ndc11 | package | 72090002301 | derived:openfda.package_ndc |
| rxcui | 1020477 | openfda.rxcui | |
| spl id | 9a01f49e-a58c-4f33-8be5-2106487f6cb6 | id | |
| spl set id | 9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa | 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.