Home › NDC Lookup › Ingredients › Fluorescein Sodium › 83851-0100-10
C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mg Strip, 100 packets — NDC 83851-0100-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mg Strip, 100 packets — NDC 83851-100-10 (Billing 83851-0100-10)

by Vistamerica USA · 100 PACKET in 1 BOX / 1 mg in 1 PACKET

This is a package of 100 packets of C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mg Strip from Vistamerica USA, marketed since Oct 2024 and currently FDA-listed.

NDC 83851-0100-10
🏷️ FDA NDC (as labeled) 83851-100-10 billing pads the product segment with a zero
This package
Contains100 packets Pack sizes3 compare ↓
Product page 83851-0100-05 Also comes in: 50 packets 83851-100-05 300 packets 83851-100-30
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 83851-100-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83851 labeler · 100 product · 10 package
Package marketed since
Oct 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8385110010 6
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Dec 31, 2025 — Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. (Wizcure Pharmaa Private Limited) · FDA recall D-0350-2026
Lots / codes: All lots · reported Mar 4, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Fluorescein Sodium (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 19, 2024 — Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. (Nomax Inc) · FDA recall D-0462-2024
Class II · Apr 19, 2024 — Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities. (Nomax Inc) · FDA recall D-0463-2024
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) 83851-100-10
Product NDC 83851-100
11-digit billing NDC 83851010010
UNII 93X55PE38X
SPL Set ID 292abb69-84ad-4f61-e063-6394a90a1447
Established class (EPC) Diagnostic Dye
Mechanism of action Dyes
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-01
Route OPHTHALMIC
Dosage form STRIP
Substance FLUORESCEIN SODIUM

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

GCN Seq No 006834
GCN 27831
HICL code 002908
Ingredient (HICL) Fluorescein Sodium
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2U
Therapeutic class — specific (HIC3) Eye Diagnostic Agents
AHFS code 36:58.00.00
AHFS class Ocular Disorders
FDB label name FLUORESCEIN 1 MG OPHTH STRIP
FDB brand name Fluorescein Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006834
  • GCN: 27831
  • HICL (First Databank): 002908
  • AHFS class code: 36:58.00.00
Why two NDCs? The FDA registers this code as 83851-100-10 — 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 → 83851-0100-10. 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 FLUORESCEIN 1 MG OPHTH STRIP Ingredient Fluorescein Sodium
🧪 What is this product?

Fluorescein sodium ophthalmic strips are single-use eye inserts containing fluorescein sodium, a water-soluble dye. This product is marketed without an FDA-approved application. Fluorescein sodium is typically used in eye exams and diagnostic procedures to help eye care professionals visualize the surface of the eye and detect scratches, ulcers, or foreign objects. The dye absorbs light and fluoresces under special lighting, making abnormalities easier to see during examination.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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.
Try another pack size: 50 packets 300 packets
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
83851-0100-05 83851-100-05 Main listing 50 PACKET in 1 BOX / 1 mg in 1 PACKET 2024-10-01 — Active
83851-0100-10 You're viewing this 100 PACKET in 1 BOX / 1 mg in 1 PACKET 2024-10-01 — Active
83851-0100-30 83851-100-30 300 PACKET in 1 BOX / 1 mg in 1 PACKET 2024-10-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 100 packets — 100 packet in 1 box / 1 mg in 1 packet.
How does this package differ from NDC 83851-0100-05?
Both are C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mg Strip — the drug itself is identical. This page's package is the 100 packets one, while NDC 83851-0100-05 is the 50 packets package.
What NDC number is used to bill for this package of C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mg Strip?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips 1 mg/mgthis 83851-0100-10 Vistamerica 100 packets — — 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerVistamerica USA
Labeler code83851
First marketedOct 2024
Product typeHuman Prescription Drug
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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 90 words ▾

INDICATIONS: Intended for use when fitting contact lenses.

DIRECTIONS FOR USE: To insure full fluorescence and patient comfort, the impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip.

It is recommended that the patient blink several times after application. Grasp tabs between thumbs & index fingers Gently pull tabs apart Remove strip taking care to touch only the white portion of the strip 83851-100: Vista Fluroescein Sodium

📦 How Supplied / Storage and Handling 10 words ▾

HOW SUPPLIED: Dispenser carton containing 50, 100, or 300 strips.

📦 Storage and Handling 10 words ▾

STORAGE: Store at 10 o C - 30 o C.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Package Label / Principal Display Panel 76 words ▾

Representative Packaging: 83851-100: Fluorescein Sodium Ophthalmic Strip Individual Pouch (Wizcure) (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (Wizcure) (above) 83851-100: Fluorescein Sodium How Used (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Individual Pouch (above) 83851-100: Fluorescein Sodium Ophthalmic Pouch (Wizcure) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (Wizcure) 83851-100: Fluorescein Sodium Ophthalmic Strip How Used (above) 83851-100: Fluorescein Sodium Ophthalmic Strip Box (above) Vista Fluorescein Sodium Ophthalmic Strip (Individual Pouch) 83851-100

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

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 ✓ Available
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 — 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 Drug Other". 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 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 Vistamerica USA. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 50 packets (83851-0100-05), 300 packets (83851-0100-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Vistamerica USA 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.
← 83850-0300-00 · PAPATUI, 83852-0438-03 · ALLIES →
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.