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CVS Health Fast Acting Lubricant Eye Drops Polyethylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops — NDC 51316-0659-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Health Fast Acting Lubricant Eye Drops Polyethylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops — NDC 51316-659-01 (Billing 51316-0659-01)

by CVS Pharmacy, Inc. · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER

This is a package of CVS Health Fast Acting Lubricant Eye Drops Polyethylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops from CVS Pharmacy, Inc., marketed since Jan 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51316-0659-01
🏷️ FDA NDC (as labeled) 51316-659-01 billing pads the product segment with a zero
This package
Contains15 mL in 1 bottle, dropper Pack sizes2 compare ↓
Main listing for product 51316-659 · Also comes in: 2 bottles 51316-659-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

⚠️
Other active recalls for Polyethylene Glycol 400, Propylene Glycol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0412-2026
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) 51316-659-01
Product NDC 51316-659
11-digit billing NDC 51316065901
RxCUI 477589
UNII 6DC9Q167V3, B697894SGQ
UPC 0050428447383, 0050428396902
Application # M018
SPL Set ID 31addfd2-52f2-05b3-e063-6294a90a337f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PROPYLENE GLYCOL; POLYETHYLENE GLYCOL 400
Quick answers
  • RxCUI (RxNorm): 477589
Why two NDCs? The FDA registers this code as 51316-659-01 — 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 → 51316-0659-01. 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?

CVS Health Fast Acting Lubricant Eye Drops is an over-the-counter eye drop solution containing polyethylene glycol 400 and propylene glycol. These are lubricating agents typically used to relieve dryness and irritation on the eye surface. The product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and quality standards for this category of eye lubricants rather than being individually reviewed.

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 mLPer 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: 2 bottles
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
51316-0659-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 — Active
51316-0659-02 51316-659-02 2 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER 2024-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 box / 15 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of CVS Health Fast Acting Lubricant Eye Drops Polyethylene glycol 400, Propylene .3 g/100mL; 400 .4 g/100mL Solution/ Drops?
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
Leader Lubricant Eye Drops 30ct 400 .4 g/100mL; .3 g/100mL 70000-0017-01 CARDINAL 30 vials $0.204 — Availability likely —
Leader Preservative-Free Ultra Lubricating Eye Drops 400 .4 g/100mL; .3 g/100mL 70000-0501-01 Cardinal 25 vials $0.211 — Availability likely —
Sunmark Lubricating Tears 400 .4 g/100mL; .3 g/100mL 49348-0149-29 Strategic 1 bottle $0.332 — FDA listed —
Sunmark Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 49348-0947-29 Strategic 1 bottle $0.332 — FDA listed —
Health Mart Lubricating Tears 400 .4 g/100mL; .3 g/100mL 62011-0254-01 Strategic 1 bottle $0.332 — FDA listed —
Lubricant Eye Drops Solution 400 4 mg/mL; 3 mg/mL 50268-0126-15 AvPAK 1 bottle $0.363 — Availability likely —
Leader Ultra Lubricating Eye Drops 400 .4 g/100mL; .3 g/100mL 70000-0457-01 Cardinal 1 bottle $0.363 — Availability likely —
Foster and Thrive Lubricating Tears Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 70677-1160-01 Strategic 1 bottle $0.363 — Availability likely —
Foster and Thrive Long Lasting Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 70677-1162-01 Strategic 1 bottle $0.363 — Availability likely —
Quality Choice Lubricant Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 83324-0029-15 Chain 1 bottle $0.363 — Availability likely —
Systane 400 4 mg/mL; 3 mg/mL 00065-0431-33 Alcon 30 vials $0.376 — Availability likely —
Systane Hydration Pf Preservative Free 400 4 mg/mL; 3 mg/mL 00065-1437-04 Alcon 30 vials $0.376 — Availability likely —
Systane Lubricant 400 4 mg/mL; 3 mg/mL 00065-0429-15 Alcon 1 bottle $0.702 — Availability likely —
Systane Ultra Preservative Free 400 4 mg/mL; 3 mg/mL 00065-1507-82 Alcon 1 bottle $1.155 — Availability likely —
Systane Hydration Pf Preservative Free 400 4 mg/mL; 3 mg/mL 00065-1510-06 Alcon 1 bottle $1.155 — Availability likely —
Systane Ultra 400 4 mg/mL; 3 mg/mL 00065-1431-01 Alcon 1 bottle — — FDA listed —
Systane ULTRA 400 4 mg/mL; 3 mg/mL 00065-1432-04 Alcon 5 vials — — FDA listed —
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack .3 g/100mL; 400 .4 g/100mL 00363-4549-01 Walgreen 1 bottle — — FDA listed —
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack 400 .4 g/100mL; .3 g/100mL 00363-4551-01 Walgreen 1 bottle — — FDA listed —
Walgreens Lubricant 3 mg/mL; 400 4 mg/mL 00363-6153-05 Walgreens 1 bottle — — FDA listed —
Walgreens Ultra Lubricant 400 4 mg/mL; 3 mg/mL 00363-6154-05 Walgreens 1 bottle — — FDA listed —
Target Lubricant Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 11673-0101-01 Target 1 bottle — — FDA listed —
Target Lubricant Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 11673-0110-01 Target 2 bottles — — FDA listed —
Rite Aid Hydration Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 11822-0203-01 Rite 1 bottle — — FDA listed —
Signature Care Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 21130-0702-01 Better 1 bottle — — FDA listed —
Signature Care Lubricant Eye Drops Long Lasting 400 .4 g/100mL; .3 g/100mL 21130-0756-01 Better 1 bottle — — FDA listed —
Kroger High Performance Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 30142-0333-01 Kroger 1 bottle — — FDA listed —
Topcare Health Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 36800-0978-01 Topco 1 bottle — — FDA listed —
Meijer Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 41250-0319-01 Meijer 1 bottle — — FDA listed —
Meijer Ultra Lubricant Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 41250-0937-01 Meijer 1 bottle — — FDA listed —
Equate Lubricant Eye Drops High Performance .3 g/100mL; 400 .4 g/100mL 49035-0282-01 Wal-Mart 2 bottles — — FDA listed —
Equate Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 49035-0528-02 Wal-Mart 2 bottles — — FDA listed —
GoodSense Ultra Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 50804-0160-01 Geiss, 1 bottle — — FDA listed —
CVS Hydration Eye Drops .3 g/100mL; 400 .4 g/100mL 51316-0615-10 CVS 1 bottle — — FDA listed —
CVS Health Fast Acting Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mLthis 51316-0659-01 CVS 1 bottle — — FDA listed —
Retaine Ultra PF 400 4 mg/mL; 3 mg/mL 54799-0470-10 OCuSOFT 10 ml — — FDA listed —
Exchange Select High Performance Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 55301-0347-01 Army 1 bottle — — FDA listed —
Medics Choice Fresh and Soothe Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 55651-0999-01 KC 1 bottle — — FDA listed —
DG Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 55910-0364-01 Dolgencorp 1 bottle — — FDA listed —
Publix High Performance Eye Drops .3 g/100mL; 400 .4 g/100mL 56062-0790-01 Publix 1 bottle — — FDA listed —
Harris Teeter Ultra Lubricant Eye Drops .3 g/100mL; 400 .4 g/100mL 69256-0980-01 Harris 1 bottle — — FDA listed —
CVS Lubricant Eye Drops Original 400 .4 g/100mL; .3 g/100mL 69842-0746-01 CVS 30 vials — — FDA listed —
Equate Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 79903-0131-30 Walmart, 30 vials — — FDA listed —
Avenova Lubricant Eye Drops High Performance 400 .4 g/100mL; .3 g/100mL 81963-0101-10 NovaBay 2 bottles — — FDA listed —
CorneaCare Recover Lubricant Eye Drops 400 .4 g/100mL; .3 g/100mL 82875-0002-01 CorneaCare 1 bottle — — FDA listed —
Quality Choice Lubricant Eye Drops Long Lasting 400 .4 g/100mL; .3 g/100mL 83324-0030-15 Chain 1 bottle — — FDA listed —
Archies Dry Eye Relief 400 .4 g/100mL; .3 g/100mL 83737-0001-30 Archie's 30 vials — — 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
Jan 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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 aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, sorbitol

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

LabelerCVS Pharmacy, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio129 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use for the temporary relief of burning and irritation due to dryness of the eye

⏱️ Dosage and Administration 12 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) as needed

⚠️ Warnings 106 words ▾

Warnings For external use only Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye(s) gets worse or lasts more than 72 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 7 words ▾

Active ingredients Polyethylene glycol 400......0.4% Propylene glycol......0.3%

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, sorbitol

🎯 Purpose 6 words ▾

Purpose Polyethylene glycol 400......Lubricant Propylene glycol......Lubricant

📄 Do Not Use 21 words ▾

Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product

📄 When Using This Product 21 words ▾

When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye(s) gets worse or lasts more than 72 hours

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Other Information 6 words ▾

Other information Store at 15º-30°C (59°-86ºF)

📄 Package Label / Principal Display Panel 36 words ▾

CVS Health Fast Acting Lubricant Eye Drops 15mL CVS Health Fast Acting Lubricant Eye Drops 15mL

CVS Health Fast Acting Lubricant Eye Drops 15mL twin pk CVS Health Fast Acting Lubricant Eye Drops 15mL twin pk

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 CVS Health Fast Acting Lubricant Eye Drops (this brand).

Top reported reactions

Cataract3
Dermatitis Atopic3
Dyspepsia3
Dysphagia3
Gastroenteritis3
Corneal Infection1
Corneal Scar1

Reporter sex

4 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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.

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 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 CVS Pharmacy, Inc.. 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 2 bottles (51316-0659-02). 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?
CVS Pharmacy, 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.
← 51316-0657-03 · CVS 51316-0662-03 · CVS →
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.