Diclolidol Kit
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
- Diclolidol Kit
- Generic name
- LIDOCAINE HCL, DICLOFENAC SODIUM
- Manufacturer
- PureTek Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3e63324b-e761-9367-e063-6394a90a2981
- SPL ID
- 3e63324b-e762-9367-e063-6394a90a2981
- Version
- 1
- Effective date
- 2025-09-09
- Source export date
- 2026-09-28
- 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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:46:05
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 |
|---|---|---|---|
| brand name | Diclolidol Kit | openfda.brand_name | |
| generic name | LIDOCAINE HCL, DICLOFENAC SODIUM | openfda.generic_name | |
| manufacturer name | PureTek Corporation | openfda.manufacturer_name | |
| ndc | package | 59088-327-07 | openfda.package_ndc |
| ndc | package | 59088-806-00 | openfda.package_ndc |
| ndc | package | 43598-977-10 | openfda.package_ndc |
| ndc | product | 59088-806 | openfda.product_ndc |
| ndc11 | package | 59088032707 | derived:openfda.package_ndc |
| ndc11 | package | 43598097710 | derived:openfda.package_ndc |
| ndc11 | package | 59088080600 | derived:openfda.package_ndc |
| rxcui | 855633 | openfda.rxcui | |
| rxcui | 1010057 | openfda.rxcui | |
| spl id | 3e63324b-e762-9367-e063-6394a90a2981 | id | |
| spl set id | 3e63324b-e761-9367-e063-6394a90a2981 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings: see full prescribing information for Diclofenac Sodium For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. Liver warning: This product contains diclofenac. Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: T his product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
warnings
WARNINGS: For external use only. Not for ophthalmic use. PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral® 5% Roll on Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine. Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted. Use in Pregnancy: Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother. Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.