Dimenhydrinate
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
- Dimenhydrinate
- Generic name
- DIMENHYDRINATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- bc71539e-1a33-4709-8a24-c2894e8dbc1c
- SPL ID
- b3e3433d-c18b-4ed3-b2ba-1e550474ca33
- Version
- 5
- Effective date
- 2025-01-15
- Source export date
- 2026-09-28
- 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/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:33:34
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS |
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 applno | ANDA | 040519 | derived:openfda.application_number |
| application number | ANDA040519 | openfda.application_number | |
| brand name | Dimenhydrinate | openfda.brand_name | |
| generic name | DIMENHYDRINATE | openfda.generic_name | |
| manufacturer name | Fresenius Kabi USA, LLC | openfda.manufacturer_name | |
| ndc | package | 63323-366-01 | openfda.package_ndc |
| ndc | package | 63323-366-00 | openfda.package_ndc |
| ndc | product | 63323-366 | openfda.product_ndc |
| ndc11 | package | 63323036601 | derived:openfda.package_ndc |
| ndc11 | package | 63323036600 | derived:openfda.package_ndc |
| rxcui | 309914 | openfda.rxcui | |
| spl id | b3e3433d-c18b-4ed3-b2ba-1e550474ca33 | id | |
| spl set id | bc71539e-1a33-4709-8a24-c2894e8dbc1c | set_id | |
| unii | JB937PER5C | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Caution should be used when dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since dimenhydrinate is capable of masking ototoxic symptoms, and an irreversible state may be reached. This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Therefore, patients should be warned accordingly. Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias). The preparation should not be injected intra-arterially. Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
warnings
Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The most frequent adverse reaction to dimenhydrinate is drowsiness. Dizziness may also occur. Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.