Sodium Chloride Normal Salt 1 g Tablet, 100-count
by Method Pharmaceuticals · 100 TABLET in 1 BOTTLE (58657-118-01)
NDC 58657-0118-01
🏷️ FDA NDC (as labeled)
58657-118-01
billing pads the product 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 Sodium 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 II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
58657-118-01
Product NDC
58657-118
11-digit billing NDC
58657011801
NCPDP billing unit
EA — each (per item)
RxCUI
313009
UNII
451W47IQ8X
Application #
M018
SPL Set ID
ce84727a-3677-4bf0-e053-2995a90a3ec8
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-09-23
Route
ORAL
Dosage form
TABLET
Substance
SODIUM CHLORIDE
GPI-14
79750010000320
GPI class
Sodium Chloride
GCN Seq No
060491
GCN
26657
HICL code
000538
Ingredient (HICL)
Sodium Chloride
HIC1 code
C
Therapeutic class — broad (HIC1)
Electrolyte Balance/Metabolism/Nutrition
HIC2 code
C1
Therapeutic class — intermediate (HIC2)
Drugs Affecting Electrolyte Balance
HIC3 code
C1B
Therapeutic class — specific (HIC3)
Sodium/Saline Preparations
AHFS code
92:92.00.00
AHFS class
Other Miscellaneous Therapeutic Agents
FDB label name
SODIUM CHLORIDE 1 GM TABLET
FDB brand name
Sodium Chloride
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 58657-118-01 — a 5-3-2 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 product segment → 58657-0118-01. 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.
🏷️ RxNorm drug class
This medicine belongs to the Sodium class.
Drug family (ATC)
Sodium, Salt solutions, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerMethod Pharmaceuticals
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code58657
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio11 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
Label name SODIUM CHLORIDE 1 GM TABLET Ingredient Sodium Chloride
📗 Our plain-language guide HelloPharmacist
- Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
- I've heard of saline solution — is that the same thing as sodium chloride?
- In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
- Why would someone need sodium chloride through an IV? Can't you just drink water?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sodium Chloride — 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 sodium chloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeRound
ImprintM118
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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.
From the label’s inactive-ingredient sectionNONE
This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.069 | $6.91 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2106 | $21.06 / 100 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 8% over the last 11 months.
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride 1000 mg 57237-0361-01 | Rising | 100 tablets | $0.069 | — | Availability likely | — |
| Sodium Chloride Normal Salt 1 gthis 58657-0118-01 | Method | 100 tablets | $0.069 | — | Availability likely | — |
| Sodium Chloride 1000 mg 81033-0028-01 | Kesin | 100 tablets | $0.069 | — | Availability likely | — |
| Normal Salt 1 g 55681-0305-03 | Twin | 200 tablets | — | — | FDA listed | — |
| Sodium Chloride Normal Salt 1 g 55681-0333-02 | TWIN | 200 tablets | — | — | FDA listed | — |
| Sodium Chloride 1 g 58657-0119-01 | Method | 100 tablets | — | — | FDA listed | — |
| Sodium Chloride Normal Salt 1 g 70369-0007-02 | Citragen | 500 tablets | — | — | FDA listed | — |
| Normal Salt 1 g 70795-1120-00 | GRAXCELL | 1000 tablets | — | — | FDA listed | — |
| Sodium Chloride 1 Gram 77333-0835-10 | Gendose | 100 tablets | — | — | Discontinued | — |
| Sodium Chloride 1 Gram 77333-0844-10 | Gendose | 100 tablets | — | — | Discontinued | — |
| Sodium Chloride 1 Gram 77333-0846-10 | Gendose | 1000 tablets | — | — | FDA listed | — |
| Sodium Chloride Normal Salt 1 g 80513-0608-01 | Advanced | 100 tablets | — | — | FDA listed | — |
| Sodium Chloride 1000 mg 84447-0002-01 | Belleview | 100 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
🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 58657-0118-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.8K
Units reimbursed last 4 qtrs
345.7K
Gross reimbursed last 4 qtrs
$72.8K
Avg / prescription
$15.19
Avg / unit
$0.2106
Latest quarter Q4 2025
1.2KRx
Medicaid pays / ea
$0.2106
gross reimbursed
vs
NADAC / ea
$0.0691
acquisition cost
=
Spread
+$0.1415
+205% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 2,478 Rx Managed care · 2,316 Rx
State Medicaid map
Units reimbursed · per 100k residents
7.51,093
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Sodium Chloride (matched by generic name) — the program that covers self-administered drugs. 2 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 Sodium Chloride. 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
$16.2K
Claims incl. refills
266
Beneficiaries
53
Spend / beneficiary
$304.99
Spend / claim
$60.77
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 Sodium Chloride Normal Salt (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
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 |
|---|---|---|---|
| 58657-0118-01 You're viewing this | 100 TABLET in 1 BOTTLE (58657-118-01) | 2021-09-28 | Active |
📄 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 ▾
Indication Electrolyte Replenisher
⏱️ Dosage and Administration ▾
Directions to make isotonic solutions of sodium chloride, dissolve one tablet in 120 mL (four ounces) of distilled water and use as directed by a physician. if used an electrolyte replinisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by a physician.
⚠️ Warnings ▾
Warnings Do not use without consulting a physician.
🧪 Active Ingredient ▾
Active ingredients Sodium Chloride
🧪 Inactive Ingredients ▾
Inactive Ingredient NONE
🎯 Purpose ▾
Uses for the normal preparation of isotonic solution of sodium chloride as an electrolyte replinisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician
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.