Home › NDC Lookup › Ingredients › Sodium Chloride › 00536-1254-94
Sodium Chlorode Hypertonicity Ophthalmic Solution sodium chloride 50 mg/mL Solution — NDC 00536-1254-94 package photo

Sodium Chlorode Hypertonicity Ophthalmic Solution sodium chloride 50 mg/mL Solution

by Rugby Laboratories · 1 BOTTLE in 1 CARTON (0536-1254-94) / 15 mL in 1 BOTTLE
NDC 00536-1254-94
🏷️ FDA NDC (as labeled) 0536-1254-94 billing pads the labeler 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 0536-1254-94
Product NDC 0536-1254
11-digit billing NDC 00536125494
NCPDP billing unit ML — per mL (volume)
RxCUI 730780
UNII 451W47IQ8X
Application # M018
SPL Set ID 822d25c0-71b3-421d-b702-4cded0c4ca32
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-17
Route OPHTHALMIC
Dosage form SOLUTION
Substance SODIUM CHLORIDE
GPI-14 86804030102005
GPI class Sodium Chloride (Hypertonic)
GCN Seq No 007739
GCN 31923
HICL code 003389
Ingredient (HICL) Sodium Chloride
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6A
Therapeutic class — specific (HIC3) Ophthalmic Preparations, Miscellaneous
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name SODIUM CHLORIDE 5% EYE DROP
FDB brand name Sodium Chloride
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1254-94 — a 4-4-2 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 labeler segment → 00536-1254-94. 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

LabelerRugby Laboratories
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio149 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 5% EYE DROP 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?
📖 Read our full Sodium Chloride guide →
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.

🧪 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 R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII B1QE5P712K
    Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesboric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.320 $4.80 / 15 ml
Medicaid paysCMS SDUD · 12 mo $0.7763 $11.64 / 15 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.587 $0.269
▼ Down 21% over the last 24 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chlorode Hypertonicity Ophthalmic Solution 50 mg/mLthis 00536-1254-94 Rugby 1 bottle $0.320 — Availability likely —
Muro 128 50 mg/mL 24208-0277-15 Bausch 1 bottle $1.116 — Availability likely +249%
Sodium Chloride 50 mg/mL 00363-0193-13 Walgreen 1 bottle — — FDA listed —
Walgreens 50 mg/mL 00363-0658-05 Walgreen 1 bottle — — FDA listed —
Altachlore Sodium Chloride Hypertonicity 50 mg/mL 59390-0183-13 Altaire 1 bottle — — FDA listed —
Sodium Chloride Hypertonicity Ophthalmic Solution, 5% 50 mg/mL 69618-0077-55 Reliable 1 bottle — — FDA listed —
Sodium Chloride Hypertonicity 50 mg/mL 69842-0284-15 CVS 1 bottle — — 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 00536-1254-94, 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
10.6K
Units reimbursed last 4 qtrs
168.5K
Gross reimbursed last 4 qtrs
$130.8K
Avg / prescription
$12.32
Avg / unit
$0.7763
Latest quarter Q4 2025
2.5KRx
Medicaid pays / mL
$0.7763
gross reimbursed
vs
NADAC / mL
$0.3202
acquisition cost
=
Spread
+$0.4561
+142% vs cost
What Medicaid paid per mL (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 ⓘ
79% FFS 21% MCO
Fee-for-service · 8,417 Rx Managed care · 2,195 Rx
State Medicaid map
Alaska: no data reported AK Maine: 705 units · 50.5 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 10,710 units · 187 per 100k residents MN Wisconsin: no data reported WI Michigan: 2,610 units · 26.0 per 100k residents MI New York: 60,149 units · 307 per 100k residents NY Vermont: 810 units · 125 per 100k residents VT New Hampshire: no data reported NH Oregon: 435 units · 10.3 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 615 units · 19.2 per 100k residents IA Illinois: 6,345 units · 50.6 per 100k residents IL Indiana: 375 units · 5.5 per 100k residents IN Ohio: 3,660 units · 31.1 per 100k residents OH Pennsylvania: 7,685 units · 59.3 per 100k residents PA New Jersey: 3,600 units · 38.8 per 100k residents NJ Massachusetts: no data reported MA California: 63,450 units · 163 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 180 units · 9.1 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,435 units · 16.5 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 345 units · 31.5 per 100k residents RI Arizona: 750 units · 10.1 per 100k residents AZ New Mexico: 195 units · 9.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 360 units · 6.7 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,065 units · 13.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.5307
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
🏆 Top states by units · per 100k residents
1 New York 307 /100k
2 Minnesota 187 /100k
3 California 163 /100k
4 Vermont 125 /100k
5 Pennsylvania 59.3 /100k
6 Illinois 50.6 /100k
7 Maine 50.5 /100k
8 New Jersey 38.8 /100k
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1254-94 You're viewing this 1 BOTTLE in 1 CARTON (0536-1254-94) / 15 mL in 1 BOTTLE 2020-09-17 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 6 words ▾

Uses temporary relief of corneal edema

⏱️ Dosage and Administration 21 words ▾

Directions instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.

⚠️ Warnings 77 words ▾

Warnings Do not use except under the advice and supervision of a doctor if solution changes color or becomes cloudy When using this product it may cause temporary burning and irritation to avoid contamination do not touch tip of container to any surface replace cap after use Stop use and ask a doctor if condition worsens or persists for more than 72 hours you experience eye pain, changes in vision, continued redness or irritation of the eye

🧪 Active Ingredient 5 words ▾

Active ingredients Sodium chloride 5%

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.

🎯 Purpose 3 words ▾

Purpose Hypertonicity agent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1253-91 · Rugby 00536-1256-28 · RUGBY →
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.