KALI MURIATICUM potassium chloride 6 [hp_X]/1 Tablet, 500-count
by Hyland's Inc. · 500 TABLET in 1 BOTTLE, PLASTIC (54973-5224-1)
NDC 54973-5224-01
🏷️ FDA NDC (as labeled)
54973-5224-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Potassium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0181-2026
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0180-2026
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq (ICU Medical, Inc.) · FDA recall D-0268-2025
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. (ICU Medical, Inc.) · FDA recall D-0267-2025
Class II · Jan 30, 2025 — Failed Dissolution Specifications. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0221-2025
Class I · Jun 25, 2024 — Failed Dissolution Specifications (Amerisource Health Services LLC) · FDA recall D-0619-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
54973-5224-1
Product NDC
54973-5224
11-digit billing NDC
54973522401
UNII
660YQ98I10
UPC
0354973522411
SPL Set ID
2e8a4762-d28d-4b64-892f-913e04d18d2d
Established class (EPC)
Osmotic Laxative; Potassium Salt
Mechanism of action
Osmotic Activity
Physiologic effect
Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class
Potassium Compounds
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1940-01-01
Route
ORAL
Dosage form
TABLET
Substance
POTASSIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 54973-5224-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 54973-5224-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerHyland's Inc.
Labeler code54973
First marketedJan 1940
Product typeHuman Otc Drug
Portfolio68 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- You're right that food is the first line — bananas, potatoes, and leafy greens are all rich in potassium. But sometimes diet alone isn't enough, especially if you're taking a diure...
- Why did my doctor prescribe potassium chloride? I thought potassium just came from bananas.
- Yes — always take oral tablets or capsules with a meal or right after eating. Taking them on an empty stomach can irritate or even ulcerate the lining of your stomach or intestines...
- Do I have to take it with food? What happens if I forget?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Potassium Chloride (prescription drug) — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about potassium chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
-
UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesIn a base of Acacia Gum, Lactose N.F. “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Kali Muriaticum 6 [hp_X]this 54973-5224-01 | Hyland's | 500 tablets | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
1940
On the market since
Jan 1940
📍
2026
Currently FDA-listed
86 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Potassium Chloride (matched by generic name) — the program that covers self-administered drugs. 42 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Potassium Chloride. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for KALI MURIATICUM (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 54973-5224-01 You're viewing this | 500 TABLET in 1 BOTTLE, PLASTIC (54973-5224-1) | 1940-01-01 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
KALI MURIATICUM potassium chloride 6 [hp_X]/1 TABLET is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 54973-5224-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 54973-5224-01, written without dashes as 54973522401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 54973-5224-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (5224) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hyland's Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hyland's Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
INDICATIONS Relief of symptoms of colds, sore throat and runny nose with a white discharge.
⏱️ Dosage and Administration ▾
DIRECTIONS Adults & Children ages 7 - 12: 4 tablets. Children ages 2 - 6: 2 tablets. Dissolve under tongue 3 times a day. Use more frequently (every 15 minutes for up to 8 doses) with acute conditions.
⚠️ Warnings ▾
Warnings Do not use if imprinted cap band is broken or missing. If symptoms persist for more than seven days or worsen, contact a licensed health care provider. Discontinue use if symptoms are accompanied by a high fever (over 101° F).
Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under three years of age unless directed by physician.
If you are pregnant or nursing, seek the advice of a licensed health care provider before using this product. Keep this and all medications out of the reach of children.
🧪 Active Ingredient ▾
FORMULA Kali Muriaticum 6X HPUS In a base of Acacia Gum, Lactose N.F. “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
🧪 Inactive Ingredients ▾
In a base of Acacia Gum, Lactose N.F. “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
🎯 Purpose ▾
Relief of symptoms of colds, sore throat and runny nose with a white discharge.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.