👁️image loading
(from DailyMed)

Sunmark Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops — NDC 49348-095-29 (Billing 49348-0095-29)

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC

This is a package of Sunmark Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops from Strategic Sourcing Services LLC, marketed since May 2013 and currently FDA-listed; retail pharmacies pay about $0.1597 per mL (NADAC). It is this product's only package size.

NDC 49348-0095-29
🏷️ FDA NDC (as labeled) 49348-095-29 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

NDC database record

One package, one record: these facts belong to NDC 49348-095-29 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49348 labeler · 095 product · 29 package
Package marketed since
May 1, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4934809529 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycerin, Hypromellose, Polyethylene Glycol 400 (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 · Jun 13, 2023 — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. (K.C. Pharmaceuticals, Inc) · FDA recall D-0898-2023
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) 49348-095-29
Product NDC 49348-095
11-digit billing NDC 49348009529
NCPDP billing unit ML — per mL (volume)
RxCUI 259581
UNII 3NXW29V3WO, PDC6A3C0OX, B697894SGQ
Application # M018
SPL Set ID 043ccc34-44ee-416a-88bc-f247774e9075
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-05-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance HYPROMELLOSES; GLYCERIN; POLYETHYLENE GLYCOL 400

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

GPI-14 86209903302020
GPI class SM Dry Eye Relief
GCN Seq No 043044
GCN 92824
HICL code 020361
Ingredient (HICL) Peg 400/Hypromellose/Glycerin
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 Q6T
Therapeutic class — specific (HIC3) Artificial Tears
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name SM DRY EYE RELIEF EYE DROPS
FDB brand name Dry Eye Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 043044
  • GCN: 92824
  • GPI-14 (Medi-Span): 86209903302020
  • HICL (First Databank): 020361
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 259581
Why two NDCs? The FDA registers this code as 49348-095-29 — 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 → 49348-0095-29. 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 Viscoelastic substances class.

Drug family (ATC) Viscoelastic substances
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 SM DRY EYE RELIEF EYE DROPS Ingredient Peg 400/Hypromellose/Glycerin
🧪 What is this product?

Sunmark Dry Eye Relief is an over-the-counter eye drop solution marketed under FDA's OTC monograph rules. It contains three lubricating agents: glycerin, hypromellose, and polyethylene glycol 400. These ingredients are typically used together to coat and moisturize the eye surface, and are commonly found in artificial tear products intended to soothe dry eye discomfort.

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 $0.160 $2.40 / 15 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 Apr 2022 Aug 2022 Dec 2023 $0.160 $0.141
▲ Up 13% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49348-0095-29 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC 2013-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mLthis 49348-0095-29 Strategic 1 bottle $0.160 — FDA listed —
GNP Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 46122-0605-05 AmerisourceBergen 1 bottle $0.169 — Discontinued +6%
Leader Dry Eye Relief Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 70000-0502-01 CARDINAL 1 bottle $0.169 — Availability likely +6%
Rite Aid Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 11822-1067-02 Rite 1 bottle — — FDA listed —
TopCare Health Dry Eye Relief Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mL 36800-0845-01 Topco 1 bottle — — FDA listed —
HEB Dry Eye Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 37808-0748-01 HEB 1 bottle — — FDA listed —
Meijer Dry Eye Relief .2 g/100mL; 400 1 g/100mL; .2 g/100mL 41250-0718-01 Meijer 1 bottle — — FDA listed —
Equate Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 49035-0280-01 Wal-Mart 2 bottles — — FDA listed —
Discount Drug Mart Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 53943-0032-01 Discount 1 bottle — — FDA listed —
Exchange Select Artificial Tears Lubricant Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55301-0178-01 Army 1 bottle — — FDA listed —
Artificial Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 55651-0115-01 KC 1 bottle — — FDA listed —
DG Health Dry Eye Relief 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55910-0362-01 Dolgencorp 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 57896-0181-05 Geri-Care 1 bottle — — FDA listed —
Core Values Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 63940-0035-01 Liberty 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68071-4555-05 NuCare 15 mg — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68788-7266-00 Preferred 1 bottle — — FDA listed —
Harris Teeter Eye Drops Artificial Tears .2 g/100mL; .2 g/100mL; 400 1 g/100mL 69256-0823-01 Harris 1 bottle — — FDA listed —
Crocodile Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 87522-0115-01 Crocodile 1 bottle — — 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

🏛️
2013
On the market since
May 2013
📍
2026
Currently FDA-listed
13 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.

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

LabelerStrategic Sourcing Services LLC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code49348
First marketedMay 2013
Product typeHuman Otc Drug
Portfolio316 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 20 words ▾

​Uses for the temporary relief of burning and irritation due to dryness of the eye for protection against further irritation

⏱️ Dosage and Administration 20 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) as needed Children under 6 years of age: ask doctor

⚠️ Warnings 109 words ▾

​Warnings For external use only Do not use this product if solution changes color or becomes cloudy Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed remove contact lens before using Keep out of reach of children If accidentally swallowed get medical help or contact a Poison Control Center immediately If pregnant and breast-feeding , ask a health professional before use

🧪 Active Ingredient 9 words ▾

​Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 1%

🧪 Inactive Ingredients 23 words ▾

​Inactive ingredients dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water

🎯 Purpose 6 words ▾

​Purpose Glycerin.....Lubricant Hypromellose.....Lubricant Polyethylene glycol 400.....Lubricant

📄 Do Not Use 12 words ▾

Do not use this product if solution changes color or becomes cloudy

📄 Ask a Doctor Before Use If 33 words ▾

Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

📄 When Using This Product 29 words ▾

When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed remove contact lens before using

🤰 If Pregnant or Breast-Feeding 11 words ▾

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

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children If accidentally swallowed get medical help or contact a Poison Control Center immediately

📄 Other Information 20 words ▾

Other information RETAIN THIS CARTON FOR FUTURE REFERENCE Store at 15 o C-30 o C (59 o -86 o F)

📄 Package Label / Principal Display Panel 1 words ▾

CARTON

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

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 — 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) ✓ 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

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.
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 Strategic Sourcing Services LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strategic Sourcing Services LLC 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.