warnings
Warnings
Acetaminophen Diphenhydramine HCl
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
- Acetaminophen Diphenhydramine HCl
- Generic name
- ACETAMINOPHEN DIPHENHYDRAMINE HCL
- Manufacturer
- Chain Drug Consortium,LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 47f839b9-ac8a-161c-e054-00144ff8d46c
- SPL ID
- 47f839b9-ac8b-161c-e054-00144ff8d46c
- Version
- 1
- Effective date
- 2017-02-07
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:03:46
| 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 | part343 | openfda.application_number | |
| brand name | Acetaminophen Diphenhydramine HCl | openfda.brand_name | |
| generic name | ACETAMINOPHEN DIPHENHYDRAMINE HCL | openfda.generic_name | |
| manufacturer name | Chain Drug Consortium,LLC | openfda.manufacturer_name | |
| ndc | package | 68016-654-05 | openfda.package_ndc |
| ndc | package | 68016-654-10 | openfda.package_ndc |
| ndc | product | 68016-654 | openfda.product_ndc |
| ndc11 | package | 68016065405 | derived:openfda.package_ndc |
| ndc11 | package | 68016065410 | derived:openfda.package_ndc |
| rxcui | 1092189 | openfda.rxcui | |
| spl id | 47f839b9-ac8b-161c-e054-00144ff8d46c | id | |
| spl set id | 47f839b9-ac8a-161c-e054-00144ff8d46c | set_id | |
| unii | 8GTS82S83M | openfda.unii | |
| unii | 362O9ITL9D | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.