Calcium Chloride
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
- Calcium Chloride
- Generic name
- CALCIUM CHLORIDE INJECTION
- Manufacturer
- REMEDYREPACK INC.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3089499b-142d-482e-889d-1db4da7b1152
- SPL ID
- 59f29224-1055-e6c8-e063-6394a90aed2b
- Version
- 1
- Effective date
- 2026-08-26
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:08:13
| Harmonized routes |
|---|
| 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 | 211553 | derived:openfda.application_number |
| application number | ANDA211553 | openfda.application_number | |
| brand name | Calcium Chloride | openfda.brand_name | |
| generic name | CALCIUM CHLORIDE INJECTION | openfda.generic_name | |
| manufacturer name | REMEDYREPACK INC. | openfda.manufacturer_name | |
| ndc | package | 70518-4734-1 | openfda.package_ndc |
| ndc | package | 70518-4734-0 | openfda.package_ndc |
| ndc | product | 70518-4734 | openfda.product_ndc |
| ndc11 | package | 70518473400 | derived:openfda.package_ndc |
| ndc11 | package | 70518473401 | derived:openfda.package_ndc |
| rxcui | 828527 | openfda.rxcui | |
| spl id | 59f29224-1055-e6c8-e063-6394a90aed2b | id | |
| spl set id | 3089499b-142d-482e-889d-1db4da7b1152 | set_id | |
| unii | M4I0D6VV5M | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
10% Calcium Chloride Injection, USP is irritating to veins and must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or "heat wave". Injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local "burning" sensation and there may be a moderate fall in blood pressure. Should perivascular infiltration occur, I.V. administration at that site should be discontinued at once. Local infiltration of the affected area with 1% procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. Local application of heat may also be helpful. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.