warnings
Warnings: Do not use: ■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.
Sleep Aid
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
- Sleep Aid
- Generic name
- DIPHENHYDRAMINE HCL 25 MG
- Manufacturer
- Pioneer Life Sciences, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- a9678fed-bda5-9513-e053-2995a90a25a1
- SPL ID
- 29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69
- Version
- 6
- Effective date
- 2025-12-29
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:25:46
| 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 | Sleep Aid | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HCL 25 MG | openfda.generic_name | |
| manufacturer name | Pioneer Life Sciences, LLC | openfda.manufacturer_name | |
| ndc | package | 72090-020-10 | openfda.package_ndc |
| ndc | product | 72090-020 | openfda.product_ndc |
| ndc11 | package | 72090002010 | derived:openfda.package_ndc |
| rxcui | 1049630 | openfda.rxcui | |
| spl id | 29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69 | id | |
| spl set id | a9678fed-bda5-9513-e053-2995a90a25a1 | 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.