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PHOXILLUM

calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride, and sodium phosphate dibasic dihydrate · Injection

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PHOXILLUM BK4/2.5
Generic name
calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride, and sodium phosphate dibasic dihydrate
Dosage form
Injection
Route
Intravenous
Marketing category
NDA · NDA
Labeler
Vantive US Healthcare LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
8
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Calcium Chloride 3.68 g/L 828525 View
Magnesium Chloride 3.05 g/L 799999 View
Potassium Chloride .314 g/L 628953 View
Sodium Bicarbonate 2.21 g/L 1868486 View
Sodium Bicarbonate 3.09 g/L 1868486 View
Sodium Chloride 6.34 g/L 707251 View
Sodium Chloride 6.95 g/L 707251 View
Sodium PHOSPHATE, Dibasic .187 g/L 283100 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Intravenous
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Blood Coagulation Factor [EPC] EPC All 23 members
Calcium [CS] CS All 23 members
Calculi Dissolution Agent [EPC] EPC All 33 members
Cations EPC All 23 members
Divalent [CS] CS All 23 members
Increased Coagulation Factor Activity [PE] PE All 23 members
Increased Large Intestinal Motility [PE] PE All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] PE All 83 members
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] PE All 30 members
Magnesium Ion Exchange Activity [MoA] MoA All 30 members
Osmotic Activity [MoA] MoA All 105 members
Osmotic Laxative [EPC] EPC All 103 members
Phosphate Binder [EPC] EPC All 42 members
Phosphate Chelating Activity [MoA] MoA All 42 members
Potassium Compounds [CS] CS All 49 members
Potassium Salt [EPC] EPC All 49 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] PE All 53 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207026
Application type
NDA · New Drug Application
Approval date
January 13, 2015
Sponsor
VANTIVE US HLTHCARE
Products on application
2
Submissions recorded
6
Products approved under application 207026.
Product Trade name Form Strength Ingredient Status TE Flags
207026-001 PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER INJECTABLE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE Prescription — RLD RS
207026-002 PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER INJECTABLE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207026.
Type No. Action Status Date Review
Supplement 8 Labeling Approved May 2, 2023 Standard
Supplement 6 Labeling Approved November 1, 2018 Standard
Supplement 4 Labeling Approved June 30, 2017 Standard
Supplement 2 Labeling Approved July 20, 2016 Standard
Supplement 1 Labeling Approved December 15, 2015 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved January 13, 2015 Standard

Review documents

  • 0 · Supplement · May 3, 2023
  • 0 · Supplement · May 3, 2023
  • 0 · Supplement · December 6, 2018
  • 0 · Supplement · November 6, 2018
  • 0 · Supplement · July 5, 2017
  • 0 · Supplement · July 3, 2017
  • 0 · Supplement · July 22, 2016
  • 0 · Supplement · July 21, 2016
  • 0 · Supplement · December 17, 2015
  • 0 · Supplement · December 17, 2015
  • 0 · Original application · April 7, 2015
  • 0 · Original application · April 7, 2015
  • 0 · Original application · January 15, 2015
  • 0 · Original application · January 14, 2015

Adverse event reports

Source: openFDA FAERS
271,787
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SODIUM CHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
24571-116-06 24571-116 Vantive US Healthcare LLC 2 BAG in 1 CASE (24571-116-06) / 5 L in 1 BAG January 13, 2015
24571-117-06 24571-117 Vantive US Healthcare LLC 2 BAG in 1 CASE (24571-117-06) / 5 L in 1 BAG January 13, 2015
24571-116 24571-116 Vantive US Healthcare LLC — January 13, 2015
24571-117 24571-117 Vantive US Healthcare LLC — January 13, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.