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Sodium Chloride Hypertonicity Ophthalmic 50 mg/g Ointment, 1 tube — NDC 00536-1253-91 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Chloride Hypertonicity Ophthalmic 50 mg/g Ointment, 1 tube — NDC 0536-1253-91 (Billing 00536-1253-91)

by Rugby Laboratories · 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

This is a package of 1 tube of Sodium Chloride Hypertonicity Ophthalmic 50 mg/g Ointment from Rugby Laboratories, marketed since Nov 2020 and currently FDA-listed; retail pharmacies pay about $2.99 per g (NADAC). It is this product's only package size.

NDC 00536-1253-91
🏷️ FDA NDC (as labeled) 0536-1253-91 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 0536-1253-91 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1253 product · 91 package
Package marketed since
Nov 6, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0536125391 2
Medicaid fills, this package
5,634 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026
⚠️
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 I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
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-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0424-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0432-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0426-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1253-91
Product NDC 0536-1253
11-digit billing NDC 00536125391
NCPDP billing unit GM — per gram (weight)
Application # M018
SPL Set ID 7546770d-bc12-44b8-9fe0-fc3f5e1d12d1
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 2020-11-06
Route OPHTHALMIC
Dosage form OINTMENT
Substance SODIUM CHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 007737
GCN 31880
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 OINT
FDB brand name Sodium Chloride
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007737
  • GCN: 31880
  • HICL (First Databank): 003389
  • AHFS class code: 52:92.00.00
Why two NDCs? The FDA registers this code as 0536-1253-91 — 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 → 00536-1253-91. 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.

Clinical

Label name SODIUM CHLORIDE 5% EYE OINT Ingredient Sodium Chloride
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
  • Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
  • Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
  • What side effects should I expect with IV sodium chloride?
📖 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.

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 gPer package
Retail pharmacies payNADAC · weekly $2.990 $10.47 / 3.5 g
Medicaid paysCMS SDUD · 12 mo $4.36 $15.25 / 3.5 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Oct 2021 Jan 2024 Apr 2026 Sep 2026 $3.102 $2.753
▼ Down 4% over the last 16 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00536-1253-91 You're viewing this Main listing 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE 2020-11-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Chloride Hypertonicity Ophthalmic 50 mg/gthis 00536-1253-91 Rugby 1 tube $2.990 — Availability likely —
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye 50 mg/g 00363-7500-50 Walgreen 1 tube — — FDA listed —
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye 50 mg/g 11716-0750-00 Hanlim 1 tube — — FDA listed —
Muro 128 50 mg/g 24208-0385-01 Bausch 1 tube — — FDA listed —
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent 50 mg/g 59390-0184-50 Altaire 1 tube — — FDA listed —
Sodium Chloride Hypertonicity 50 mg/g 69842-0285-35 CVS 1 tube — — FDA listed —
Sodium Chloride Hypertonicity 50 mg/mL 73581-0708-35 YYBA 1 tube — — FDA listed —
Sodium Chloride 50 mg/g 73581-0707-01 YYBA 1 tube — — 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
Nov 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.

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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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.

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

The official label also stateslanolin, mineral oil, purified water, white petrolatum

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.

Manufacturer & labeler

LabelerRugby Laboratories
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedNov 2020
Product typeHuman Otc Drug
Portfolio149 products on file

More NDCs from Rugby Laboratories labeler code 00536

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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses temporary relief of corneal edema

⏱️ Dosage and Administration 35 words ▾

Directions pull down the lower lid of the affected eye apply a small amount (1/4 inch) of ointment to the inside of eyelid apply every 3 or 4 hours or as directed by a doctor

⚠️ Warnings 74 words ▾

Warnings For external use only Do not use except under the advice and supervision of a doctor When using this product it may cause temporary burning and irritation replace cap after use to avoid contamination do not touch tip of container to any surface 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 7 words ▾

Active ingredient Sodium chloride 50 mg (5%)

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients lanolin, mineral oil, purified water, white petrolatum

🎯 Purpose 3 words ▾

Purpose Hypertonicity agent

📄 Keep Out of Reach of Children 19 words ▾

Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 23 words ▾

Package/Label Principal Display Panel Carton Rugby ® NDC 0536-1253-91 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5% STERILE NET WT. 1/8 OZ. (3.5 G) carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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
5.6K
Units reimbursed last 4 qtrs
22.5K
Gross reimbursed last 4 qtrs
$98.2K
Avg / prescription
$17.43
Avg / unit
$4.3580
Latest quarter Q4 2025
1.8KRx
Medicaid pays / g
$4.3580
gross reimbursed
vs
NADAC / g
$2.9902
acquisition cost
=
Spread
+$1.3678
+46% vs cost
What Medicaid paid per g (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 ⓘ
71% FFS 29% MCO
Fee-for-service · 4,012 Rx Managed care · 1,622 Rx
State Medicaid map
Alaska: no data reported AK Maine: 179 units · 12.8 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: 2,867 units · 50.0 per 100k residents MN Wisconsin: no data reported WI Michigan: 410 units · 4.1 per 100k residents MI New York: 10,635 units · 54.3 per 100k residents NY Vermont: 382 units · 59.0 per 100k residents VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 39 units · 1.2 per 100k residents IA Illinois: 753 units · 6.0 per 100k residents IL Indiana: no data reported IN Ohio: 991 units · 8.4 per 100k residents OH Pennsylvania: 1,580 units · 12.2 per 100k residents PA New Jersey: 518 units · 5.6 per 100k residents NJ Massachusetts: no data reported MA California: 3,427 units · 8.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 123 units · 1.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 60 units · 0.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported 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: 581 units · 1.9 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.859.0
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 Vermont 59.0 /100k
2 New York 54.3 /100k
3 Minnesota 50.0 /100k
4 Maine 12.8 /100k
5 Pennsylvania 12.2 /100k
6 California 8.8 /100k
7 Ohio 8.4 /100k
8 Illinois 6.0 /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.

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 — the ingredient across all brands.

Top reported reactions

Fatigue14,418
Nausea14,044
Death13,396
Dyspnoea13,119
Diarrhoea11,838
Headache11,536
Vomiting11,303

Age at onset

Neonate1,750
Infant1,039
Child2,142
Adolescent1,279
Adult22,441
Elderly15,006

Reporter sex

271,788 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization113,882
Death36,286
Life-threatening17,822
Disabling8,104
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 27,226 0
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.
← 00536-1252-40 · Rugby 00536-1254-94 · 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.