Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Lubricant Eye Carboxymethylcellulose Sodium 0.5% 5 mg/mL Solution/ Drops, 30 ampules — NDC 70000-0751-1 (Billing 70000-0751-01)
by CARDINAL HEALTH 110, LLC. DBA LEADER · 30 AMPULE in 1 CARTON (70000-0751-1) / .4 mL in 1 AMPULE
NDC 70000-0751-1 (billing 70000-0751-01) is a package of 30 ampules of Lubricant Eye Carboxymethylcellulose Sodium 0.5% 5 mg/mL Solution/ Drops from CARDINAL HEALTH 110, LLC. DBA LEADER, marketed since May 2026 and currently FDA-listed.
NDC 70000-0751-01
🏷️ FDA NDC (as labeled)
70000-0751-1
billing pads the package segment with a zero
This package
Contains30 ampules
Pack sizes2 compare ↓
Also comes in:
50 ampules 70000-0751-2
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70000-0751-1
Product NDC
70000-0751
11-digit billing NDC
70000075101
RxCUI
1188426
UNII
K679OBS311
Application #
M018
SPL Set ID
51a2d74f-5ff3-9921-e063-6294a90a345a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-05-12
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Quick answers for NDC 70000-0751-1
- RxCUI (RxNorm): 1188426
- 11-digit billing NDC: 70000075101
Why two NDCs?
The FDA registers this code as 70000-0751-1 — a 5-4-1 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 package segment → 70000-0751-01. 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
🧪 What is this product?
Leader Sterile Lubricant Eye Drops is an over-the-counter eye drop solution containing carboxymethylcellulose sodium, a lubricating agent. This product is marketed as an OTC monograph drug, meaning it follows FDA's established category rules rather than being individually reviewed. Carboxymethylcellulose sodium is commonly used in eye drops to help lubricate the eye surface and is typically found in products designed to soothe dry or irritated eyes. The drops come in single-use vials for convenient application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Carboxymethylcellulose Sodium 0.5%?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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 ampules
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0751-01 70000-0751-1 You're viewing this | 30 AMPULE in 1 CARTON (70000-0751-1) / .4 mL in 1 AMPULE | 2026-05-12 | Active |
| 70000-0751-02 70000-0751-2 | 50 AMPULE in 1 CARTON (70000-0751-2) / .4 mL in 1 AMPULE | 2026-05-12 | Active |
Pack size FAQ
What quantity is in NDC 70000-0751-01?
NDC 70000-0751-01 contains 30 ampules — 30 ampule in 1 carton / .4 ml in 1 ampule.
What is the difference between NDC 70000-0751-01 and NDC 70000-0751-02?
Both are Lubricant Eye Carboxymethylcellulose Sodium 0.5% 5 mg/mL Solution/ Drops — the drug itself is identical. NDC 70000-0751-01 is the 30 ampules package, while NDC 70000-0751-02 is the 50 ampules package.
What NDC number is used to bill for this package of Lubricant Eye Carboxymethylcellulose Sodium 0.5% 5 mg/mL Solution/ Drops?
Bill NDC 70000-0751-01 — the 11-digit billing format is 70000075101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leader Lubricant Eye Drops .5 g/100mL 70000-0012-01 | Cardinal | 70 vials | $0.155 | — | Availability likely | — |
| Rugby Lubricant Eye Drops .5 g/100mL 00536-1387-92 | Rugby | 30 vials | $0.221 | — | Availability likely | — |
| Good Neighbor Pharmacy Lubricant Eye Drops .5 g/100mL 46122-0756-56 | Amerisource | 30 vials | $0.221 | — | Availability likely | — |
| carboxymethylcellulose sodium 5 mg/mL 50268-0067-30 | AvPAK | 30 vials | $0.221 | — | Availability likely | — |
| Foster and Thrive Lubricant Eye Drops .5 g/100mL 70677-1190-01 | Strategic | 30 vials | $0.221 | — | Availability likely | — |
| Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops .5 g/100mL 00536-1386-35 | Rugby | 2 bottles | $0.275 | — | Availability likely | — |
| Carboxymethylcellulose Sodium Eye Lubricant 5 mg/mL 42494-0448-05 | Cameron | 2 bottles | $0.275 | — | Discontinued | — |
| carboxymethylcellulose sodium 5 mg/mL 50268-0068-15 | AvPAK | 1 bottle | $0.365 | — | Availability likely | — |
| Leader Lubricant Eye Drops Soothing Relief .5 g/100mL 70000-0705-01 | LEADER/Cardinal | 1 bottle | $0.365 | — | Availability likely | — |
| Refresh Tears 5 mg/mL 00023-0798-01 | Allergan, | 2 bottles | $0.412 | — | Availability likely | — |
| Lubricant Drops 5 mg/mL 70000-0090-01 | CARDINAL | 1 bottle | $0.498 | — | FDA listed | — |
| Refresh Plus 5 mg/mL 00023-0403-05 | Allergan, | 5 vials | — | — | FDA listed | — |
| Refresh Tears 00023-0795-65 | Allergan, | 1 kit | — | — | FDA listed | — |
| Walgreens Lubricant Eye Drops Preservative Free .5 g/100mL 00363-8800-01 | Walgreen | 30 vials | — | — | FDA listed | — |
| Walgreens Lubricant Eye Drops 5 mg/mL 00363-8832-15 | Walgreen | 2 bottles | — | — | FDA listed | — |
| Walgreens Lubricant Eye Drops 5 mg/mL 00363-8833-15 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Lubricant Eye 5 mg/mL 00536-1476-92 | Rugby | 30 ampules | — | — | FDA listed | — |
| Lubricant Eye Drops Preservative Free .5 g/100mL 11673-0150-01 | Target | 70 vials | — | — | FDA listed | — |
| Up and Up Dry Eye Relief Lubricant Eye Drops 5 mg/mL 11673-0771-01 | Target | 2 bottles | — | — | FDA listed | — |
| Up and Up Dry Eye Relief Lubricant Eye Drops 5 mg/mL 11716-0771-01 | Hanlim | 2 bottles | — | — | FDA listed | — |
| Auro-Cmc 5 mg/mL 16030-0401-10 | Aurolab | 10 ml | — | — | FDA listed | — |
| Carboxymethylcellulose Sodium Eye Drops 0.5% 5 mg/mL 16030-0501-05 | Aurolab | 5 ml | — | — | FDA listed | — |
| Gentle Eyes Lubricant Eye Drops 5 mg/mL 17312-0430-15 | TRP | 1 bottle | — | — | FDA listed | — |
| Signature Care Lubricant Eye Drops .5 g/100mL 21130-0705-01 | Better | 30 vials | — | — | FDA listed | — |
| Kroger Lubricant Eye .5 g/100mL 30142-0373-33 | The | 30 vials | — | — | FDA listed | — |
| HEB Lubricant Eye Drops .5 g/100mL 37808-0100-01 | HEB | 30 vials | — | — | FDA listed | — |
| Medi-First Lubricant Eye Drops .5 g/100mL 47682-0193-83 | Unifirst | 30 ampules | — | — | FDA listed | — |
| Green Guard Lubricant Eye Drops .5 g/100mL 47682-0194-83 | UniFirst | 30 ampules | — | — | FDA listed | — |
| Equate Lubricant Eye Drops Preservative-Free .5 g/100mL 49035-0245-01 | Wal-Mart | 25 vials | — | — | FDA listed | — |
| Equate Restore Plus Lubricant Eye Drops .5 g/100mL 49035-0389-01 | Walmart, | 70 vials | — | — | FDA listed | — |
| Good Sense Lubricating Plus Lubricant Eye Drops .5 g/100mL 50804-0700-01 | GoodSense | 30 bottles | — | — | FDA listed | — |
| Carboxymethylcellulose Sodium 0.5% 5 mg/mL 51407-0945-30 | Golden | 3 pouches | — | — | FDA listed | — |
| Discount Drug Mart Lubricant Eye Drops 5 mg/mL 53943-0510-01 | Discount | 5 bottles | — | — | FDA listed | — |
| Retaine CMC 5 mg/mL 54799-0460-30 | OCuSOFT | 30 vials | — | — | FDA listed | — |
| Medics Choice Lubricant Eye Drops .5 g/100mL 55651-0030-01 | K.C. | 5 ampules | — | — | FDA listed | — |
| Lubricant Eye Drops 5 mg/mL 55651-0105-05 | KC | 5 bottles | — | — | FDA listed | — |
| Lubricant Eye Drops 5 mg/mL 55651-0510-01 | KC | 5 bottles | — | — | FDA listed | — |
| Publix Moisturizing Relief Eye Drops .5 g/100mL 56062-0789-01 | Publix | 30 vials | — | — | FDA listed | — |
| TheraTears Dry and Tired 5 mg/mL 58790-0013-30 | MEDTECH | 6 pouches | — | — | FDA listed | — |
| Family Care Single Use Lubricant Eye Drop 0.4mL 5ct 5 mg/mL 65923-0575-05 | United | 1 vial | — | — | FDA listed | — |
| Family Care Single Use Lubricant Eye Drop 0.4mL 30ct 5 mg/mL 65923-0576-30 | United | 30 vials | — | — | FDA listed | — |
| Refresh Tears 5 mg/mL 66715-1073-00 | Lil' | 1 bottle | — | — | Discontinued | — |
| Refresh Tears Lubricant 5 mg/mL 67751-0130-01 | Navajo | 3 ml | — | — | Discontinued | — |
| Lubricating Tears 5 mg/mL 69618-0076-55 | Reliable | 1 bottle | — | — | FDA listed | — |
| CVS Lubricant Eye Drops .5 g/100mL 69842-0804-01 | CVS | 70 vials | — | — | FDA listed | — |
| CVS Lubricant Eye Drops 30 ct .5 g/100mL 69842-0993-01 | CVS | 30 vials | — | — | FDA listed | — |
| Lubricant Eye 5 mg/mLthis 70000-0751-01 | CARDINAL | 30 ampules | — | — | FDA listed | — |
| Lubricant Eye Drops 5 mg/mL 71105-0105-05 | Redicare | 5 bottles | — | — | FDA listed | — |
| TopCare Health Lubricant Eye Drops .5 g/100mL 76162-0089-30 | Topcare | 30 vials | — | — | FDA listed | — |
| Meijer Lubricant Eye Drops .5 g/100mL 79481-0066-01 | Meijer | 30 vials | — | — | FDA listed | — |
| Rain Renewal Eye Drops .5 g/100mL 79662-0001-30 | Rain | 30 bottles | — | — | FDA listed | — |
| Equate Moisturizing Comfort Lubricant Eye Drops .5 g/100mL 79903-0264-05 | Walmart | 1 bottle | — | — | FDA listed | — |
| Focus Tears PF 5 mg/mL 82724-0009-20 | Covalent | 30 vials | — | — | FDA listed | — |
| Eyes Alive Lubricating 5 mg/mL 83291-0200-00 | RIVIERA | 100 ampules | — | — | 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
🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 M4I0D6VV5M
Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
-
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 02F3473H9O
A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
-
UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
-
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 TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
-
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 statesInactive ingredients Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
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
LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio163 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.
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Directions To open, twist and pull tab to remove. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
⏱️ Dosage and Administration ▾
Questions or comments? Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST) *This product is not manufactured or distributed by Allergan, Inc., an AbbVie company, distributor of Refresh Plus®. ©2026 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. CIN 6090088 REV.
11/25 CIN 6104301 REV. 02/26 DISTRIBUTED BY CARDINAL hEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care since 1979
⚠️ Warnings ▾
Warnings For use in the eyes only.
📦 Storage and Handling ▾
Other information Use only if tamper seal on top and bottom flaps are intact. Store between 15-30°C (59-86°F). Keep carton for complete product information.
🧪 Active Ingredient ▾
Active ingredient Purpose Carboxymethylcellulose sodium (0.5%)...............................................................Eye lubricant
🧪 Inactive Ingredients ▾
Inactive ingredients Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
🎯 Purpose ▾
Uses For the temporary relief of burning and irritation due to dryness of the eye. For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind or sun. For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Lubricant Eye (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 25%
Female · 75%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
About this NDC listing & data coverage
Over-the-counter (OTC) 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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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 "Otc Monograph Drug". 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 FDA registers it as 70000-0751-1, 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: 70000-0751-01, written without dashes as 70000075101. 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 70000-0751-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER; the middle segment (0751) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 CARDINAL HEALTH 110, LLC. DBA LEADER. 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 1 other package presentation of this same product, including 50 ampules (70000-0751-02). 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?
CARDINAL HEALTH 110, LLC. DBA LEADER 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.
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.