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

Sunmark Dry Eye Relief Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 CARTON (49348-095-29) / 15 mL in 1 BOTTLE, PLASTIC
NDC 49348-0095-29
🏷️ FDA NDC (as labeled) 49348-095-29 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ 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 →

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 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

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
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
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.

🏭 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.

🩺 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.

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.

🧪 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 IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • 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 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 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

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

The official label also states​Inactive ingredients dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water

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 $0.160 $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.

🔁 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.

🔬 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 Glycerin, Hypromellose, Polyethylene glycol 400 — the ingredient across all brands.

Top reported reactions

Eye Irritation2
Ocular Discomfort2
Vision Blurred2
Asthenopia1
Cataract1
Condition Aggravated1
Confusional State1

Reporter sex

11 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49348-0095-29 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (49348-095-29) / 15 mL in 1 BOTTLE, PLASTIC 2013-05-01 Active

📄 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
🎯 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49348-0076-44 · Strategic 49348-0133-27 · Strategic →
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.