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BSS balanced salt solution 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL Solution, 500 mL — NDC 0065-1795-04 (Billing 00065-1795-04)

by Alcon Laboratories, Inc. · 500 mL in 1 BAG

This is a package of 500 mL of BSS balanced salt solution 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL Solution from Alcon Laboratories, Inc., marketed since Mar 1969 and currently FDA-listed. It is this product's only package size.

NDC 00065-1795-04
🏷️ FDA NDC (as labeled) 0065-1795-04 billing pads the labeler segment with a zero
Rx only Brand 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 →

NDC database record

One package, one record: these facts belong to NDC 0065-1795-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0065 labeler · 1795 product · 04 package
Package marketed since
Mar 28, 1969
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
500 mL per package
Barcode (UPC-A, from the NDC)
3 0065179504 2
Medicaid fills, this package
339 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-1795-04
Product NDC 0065-1795
11-digit billing NDC 00065179504
NCPDP billing unit ML — per mL (volume)
RxCUI 806392, 806396
UNII 451W47IQ8X, 660YQ98I10, M4I0D6VV5M, 02F3473H9O, 4550K0SC9B, 1Q73Q2JULR
Application # NDA020742
SPL Set ID 28488c7b-cf6a-4a03-916f-cc66b3afdc57
Established class (EPC) Blood Coagulation Factor; Calculi Dissolution Agent; Cations; Increased Large Intestin
Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1969-03-28
Route OPHTHALMIC
Dosage form SOLUTION
Substance SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 86803010002000
GPI class BSS
GCN Seq No 053979
GCN 21768
HICL code 026132
Ingredient (HICL) Balanced Salt Irrig Soln No.2
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 Q6E
Therapeutic class — specific (HIC3) Eye Irrigations
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name BSS EYE SOLUTION
FDB brand name Bss
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 053979
  • GCN: 21768
  • GPI-14 (Medi-Span): 86803010002000
  • HICL (First Databank): 026132
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 806392
Why two NDCs? The FDA registers this code as 0065-1795-04 — 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 → 00065-1795-04. 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 Calcium class.

Drug family (ATC) Calcium, Electrolyte solutions, Acidifiers
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.

Clinical

Label name BSS EYE SOLUTION Ingredient Balanced Salt Irrig Soln No.2
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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.2279 $113.95 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00065-1795-04 You're viewing this Main listing 500 mL in 1 BAG 1969-03-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bss 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL 00065-0795-15 Alcon 15 ml — AT FDA listed —
Bss 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mLthis 00065-1795-04 Alcon 500 ml — AT FDA listed —
Balanced Salt 6.4 mg/mL; .75 mg/mL; .48 mg/mL; .3 mg/mL; 3.9 mg/mL; 1.7 mg/mL 00264-1945-10 B. 500 ml — AT Discontinued —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
1969
On the market since
Mar 1969
📍
2026
Currently FDA-listed
57 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA020742 (NDA)
Labeler code00065
First marketedMar 1969
Product typeHuman Prescription Drug
Portfolio55 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 31 words ▾

INDICATIONS AND USAGE: For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

⏱️ Dosage and Administration 72 words ▾

DOSAGE AND ADMINISTRATION: This irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

⚠️ Warnings 60 words ▾

WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. SINGLE patient use only. The contents of this bag should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.

🤒 Adverse Reactions 35 words ▾

ADVERSE REACTIONS: Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

🧬 Clinical Pharmacology 18 words ▾

CLINICAL PHARMACOLOGY: BSS Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

📦 How Supplied / Storage and Handling 61 words ▾

HOW SUPPLIED: BSS ™ Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap. 500 mL in a bag: NDC 0065-1795-04. STORAGE: Store at 36° - 77°F (2° - 25°C). Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2021 Alcon, Inc.

📋 Description 92 words ▾

DESCRIPTION: BSS ™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

⚠️ Precautions 60 words ▾

PRECAUTIONS: Open under aseptic conditions only. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed. There have been reports of corneal clouding and edema following ocular surgery in which BSS Sterile Irrigating Solution was used as an irrigating solution.

📄 Package Label / Principal Display Panel 178 words ▾

PRINCIPAL DISPLAY PANEL SINGLE PATIENT USE ONLY Rx Only NDC 0065-1795-04 BSS ™ Sterile Irrigating Solution (balanced salt solution) Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride •2H 2 O 0.048%, magnesium chloride •6H 2 O 0.03%, sodium acetate •3H 2 O 0.39%, sodium citrate •2H 2 O 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.5. The osmolality is approximately 300 mOsm/Kg.

NOT FOR I.V. USE Read accompanying insert. WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION.

Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents.

Do not use this bag for more than one patient. STORAGE: Store at 36° - 77° F (2° - 25°C). STERILE 500 mL Alcon Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA LOT : EXP .: MFD .: 300048948-0521 Storage: Store at 36° - 77°F (2° - 25°C). Do not use unless outer overwrap is intact. 9012629-1115

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 – Q1 2026 · 5 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
339
Units reimbursed last 4 qtrs
29.3K
Gross reimbursed last 4 qtrs
$6.7K
Avg / prescription
$19.68
Avg / unit
$0.2279
Latest quarter Q1 2026
81Rx
Fee-for-service vs managed care ⓘ
17% FFS 83% MCO
Fee-for-service · 58 Rx Managed care · 281 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported 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: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 143 units · 2.0 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 29,000 units · 468 per 100k residents MO Kentucky: 126 units · 2.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.0468
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 Missouri 468 /100k
2 Kentucky 2.8 /100k
3 Massachusetts 2.0 /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 Bss — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Bss. 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
$139.63
Claims incl. refills
23
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$6.07
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.

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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) ✓ Available
“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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Alcon Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alcon Laboratories, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
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.