Naphcon A naphazoline hydrochloride and pheniramine maleate .25 mg/mL; 3 mg/mL Solution/ Drops — NDC 00065-0085-42 package photo

Naphcon A naphazoline hydrochloride and pheniramine maleate .25 mg/mL; 3 mg/mL Solution/ Drops

by Alcon Laboratories, Inc. · 2 BOTTLE in 1 CARTON (0065-0085-42) / 5 mL in 1 BOTTLE
NDC 00065-0085-42
🏷️ FDA NDC (as labeled) 0065-0085-42 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 bottle Cost per mL$0.5956 NADAC Per package$5.96 / 10 ml Pack sizes2 compare ↓
Also comes in: 15 mL 00065-0085-15
OTC Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1313-2022
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0065-0085-42
Product NDC 0065-0085
11-digit billing NDC 00065008542
NCPDP billing unit ML — per mL (volume)
RxCUI 1043658, 1046266
UNII MZ1131787D, NYW905655B
Application # NDA020226
SPL Set ID 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1994-06-08
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
GPI-14 86409902142010
GPI class Naphcon-A
GCN Seq No 023718
GCN 86003
HICL code 003407
Ingredient (HICL) Naphazoline Hcl/Pheniramine
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 Q2H
Therapeutic class — specific (HIC3) Eye Antihistamine-Vasoconstrictor Combinations
AHFS code 52:32.00.00
AHFS class Vasoconstrictors
FDB label name NAPHCON-A EYE DROPS
FDB brand name Naphcon-A
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0065-0085-42 — 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 → 00065-0085-42. 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 Sympathomimetics, plain class.

Drug family (ATC) Sympathomimetics, plain, Sympathomimetics used as decongestants
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

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA020226 (NDA)
Labeler code00065
First marketedJun 1994
Product typeHuman Otc 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.

🩺 Clinical

Label name NAPHCON-A EYE DROPS Ingredient Naphazoline Hcl/Pheniramine
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves two of the most annoying allergy eye symptoms: itching and redness. The drops work when your eyes are reacting to things like pollen, ragweed, grass, or pet...
  • What exactly does this product do for my eyes?
  • Adults and children 6 and older can use 1 or 2 drops in the affected eye(s) up to 4 times a day. It's important not to use them more often than that — overusing these drops can act...
  • No — you should take your contact lenses out before putting in the drops. The label is clear on this for all of these products. You can put your contacts back in after the drops ha...
📖 Read our full Naphazoline / Pheniramine 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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid 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.

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

The official label also statesbenzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

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 $0.596 $5.96 / 10 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Mar 2022 Apr 2022 May 2022 $0.596 $0.579
▲ Up 3% over the last 4 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
Naphcon A .25 mg/mL; 3 mg/mLthis 00065-0085-42 Alcon 2 bottles $0.596 — Discontinued —
Naphcon A .25 mg/mL; 3 mg/mL 50090-0185-00 A-S 1 bottle — — FDA listed —
Visine Allergy Eye Relief Multi-Action .25 mg/mL; 3 mg/mL 69968-0367-01 Kenvue 1 bottle — — FDA listed —
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

🏛️
1994
On the market since
Jun 1994
📍
2026
Currently FDA-listed
32 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle00065-0085-15 2,241 Rx · $27,444
Drug total (last 4 qtrs): 2,241 Rx · 34,174 units · $27,444 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00065-0085-15 1 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE $0.5574 / mL $8.36 1995-01-03 Active
00065-0085-42 You're viewing this 2 BOTTLE in 1 CARTON (0065-0085-42) / 5 mL in 1 BOTTLE $0.5956 / mL $5.96 2005-01-07 Discontinued by firm

Per mL, this pack runs about 7% above the cheapest pack (NDC 00065-0085-15, $0.5574 vs $0.5956 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00065-0085-42?
NDC 00065-0085-42 is listed by the FDA — 2 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of Naphcon A naphazoline hydrochloride and pheniramine maleate .25 mg/mL; 3 mg/mL Solution/ Drops?
Bill NDC 00065-0085-42 — the 11-digit billing format is 00065008542. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 0065-0085-42, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00065-0085-42, written without dashes as 00065008542. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00065-0085-42, the first segment (00065) is the labeler code FDA assigned to Alcon Laboratories, Inc.; the middle segment (0085) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (42) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (00065-0085-15). 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?
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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 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 21 words ▾

Uses for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair

⏱️ Dosage and Administration 29 words ▾

Directions adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 12 words ▾

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid

🎯 Purpose 12 words ▾

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

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.