warnings
Warnings Do not use ■ for children under 12 years of age. ■ with any other product containing diphenhydramine, even one used on skin ■ with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Nighttime Sleep-Aid Non-Habit Forming
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 Non-Habit Forming
- Generic name
- DIPHENHYDRAMINE HCI
- Manufacturer
- AptaPharma Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- ed0ba7aa-e794-43da-b576-6b9945bf7477
- SPL ID
- f1654da1-64f7-4c2b-9201-3a7af430ba37
- Version
- 3
- Effective date
- 2023-12-30
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:43:52
| 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 | M017 | openfda.application_number | |
| brand name | Nighttime Sleep-Aid Non-Habit Forming | openfda.brand_name | |
| generic name | DIPHENHYDRAMINE HCI | openfda.generic_name | |
| manufacturer name | AptaPharma Inc. | openfda.manufacturer_name | |
| ndc | package | 76281-522-25 | openfda.package_ndc |
| ndc | package | 76281-522-28 | openfda.package_ndc |
| ndc | package | 76281-522-24 | openfda.package_ndc |
| ndc | product | 76281-522 | openfda.product_ndc |
| ndc11 | package | 76281052228 | derived:openfda.package_ndc |
| ndc11 | package | 76281052225 | derived:openfda.package_ndc |
| ndc11 | package | 76281052224 | derived:openfda.package_ndc |
| rxcui | 1248354 | openfda.rxcui | |
| spl id | f1654da1-64f7-4c2b-9201-3a7af430ba37 | id | |
| spl set id | ed0ba7aa-e794-43da-b576-6b9945bf7477 | 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.