warnings
Warnings Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.
Nighttime 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
- Nighttime Sleep-Aid
- Generic name
- DIPHENHYDRAMINE HCL
- Manufacturer
- AMERISOURCE BERGEN
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 16b2edd2-c16b-5713-e063-6394a90acf46
- SPL ID
- 44e8445b-c2fe-375a-e063-6294a90a5b91
- Version
- 3
- Effective date
- 2025-12-01
- Source export date
- 2026-10-27
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:14:02
| 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 | Nighttime Sleep-Aid | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HCL | openfda.generic_name | |
| manufacturer name | AMERISOURCE BERGEN | openfda.manufacturer_name | |
| ndc | package | 46122-775-64 | openfda.package_ndc |
| ndc | product | 46122-775 | openfda.product_ndc |
| ndc11 | package | 46122077564 | derived:openfda.package_ndc |
| rxcui | 1020477 | openfda.rxcui | |
| spl id | 44e8445b-c2fe-375a-e063-6294a90a5b91 | id | |
| spl set id | 16b2edd2-c16b-5713-e063-6394a90acf46 | 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.