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TheraTears Lubricant carboxymethylcellulose sodium 2.5 mg/mL Solution/ Drops — NDC 58790-0000-24 package photo

TheraTears Lubricant carboxymethylcellulose sodium 2.5 mg/mL Solution/ Drops

by MEDTECH PRODUCTS INC · 6 POUCH in 1 CARTON (58790-000-24) / 4 APPLICATOR in 1 POUCH / 19.2 mL in 1 APPLICATOR
NDC 58790-0000-24
🏷️ FDA NDC (as labeled) 58790-000-24 billing pads the product segment with a zero
This package
Contains19.2 mL in 1 applicator Pack sizes5 compare ↓
Also comes in: 5 pouches 58790-0000-20 6 pouches 58790-0000-00 6 pouches 58790-0000-30 8 pouches 58790-0000-32
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 Carboxymethylcellulose Sodium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 23, 2025 — cGMP deviations and lack of assurance of sterility. (BRS Analytical Services, LLC) · FDA recall D-0406-2025
Class III · Dec 18, 2024 — LABELING: LABEL MIX-UP (AvKARE) · FDA recall D-0175-2025
Class I · Nov 13, 2023 — Non-Sterility (Kilitch Healthcare India Limited) · FDA recall D-0291-2024
Class I · Nov 13, 2023 — Non-Sterility (Kilitch Healthcare India Limited) · FDA recall D-0299-2024
Class I · Oct 31, 2023 — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. (Cardinal Health Inc.) · FDA recall D-0134-2024
Class I · Oct 31, 2023 — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. (Cardinal Health Inc.) · FDA recall D-0132-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 58790-000-24
Product NDC 58790-000
11-digit billing NDC 58790000024
RxCUI 1547948, 2106821
UNII K679OBS311
Application # M018
SPL Set ID 797b0394-2f0f-4733-8d20-ec5bdf3e085d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1995-01-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
GPI-14 86200010102011
GPI class Theratears PF
GCN Seq No 030012
GCN 37385
HICL code 003843
Ingredient (HICL) Carboxymethylcellulose Sodium
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 THERA TEARS 0.25% EYE DROPS
FDB brand name Thera Tears
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 58790-000-24 — 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 → 58790-0000-24. 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.

🏭 Manufacturer & labeler

LabelerMEDTECH PRODUCTS INC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code58790
First marketedJan 1995
Product typeHuman Otc Drug
Portfolio10 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 THERA TEARS 0.25% EYE DROPS Ingredient Carboxymethylcellulose Sodium
🧪 What is this product?

TheraTears Lubricant is an over-the-counter eye drop solution containing carboxymethylcellulose sodium, a lubricating agent. This product is applied directly to the eye and is typically used to relieve dryness and irritation of the eye surface. Carboxymethylcellulose sodium functions as an artificial tear that helps coat and protect the eye. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of eye lubricants.

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 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 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 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 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 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 SE337SVY37
    A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent in liquid formulations.
  • 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.

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

The official label also statesboric acid, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium phosphate, 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 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: 5 pouches 6 pouches 6 pouches 8 pouches
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
TheraTears Lubricant 2.5 mg/mLthis 58790-0000-24 MEDTECH 6 pouches — — FDA listed —
TheraTears Lubricant 2.5 mg/mL 58790-0001-15 MEDTECH 1 bottle — — FDA listed —
TheraTears Extra 2.5 mg/mL 58790-0007-15 MEDTECH 1 bottle — — FDA listed —
TheraTears Extra 2.5 mg/mL 58790-0010-30 MEDTECH 6 pouches — — FDA listed —
Eye Drops .25 g/100mL 84938-0001-01 Foshan 2 bottles — — 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

🏛️
1995
On the market since
Jan 1995
📍
2026
Currently FDA-listed
31 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58790-0000-00 6 POUCH in 1 CARTON (58790-000-00) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL 2018-12-07 Active
58790-0000-20 5 POUCH in 1 CARTON (58790-000-20) / 4 APPLICATOR in 1 POUCH / 19.2 mL in 1 APPLICATOR 1995-01-01 Active
58790-0000-24 You're viewing this 6 POUCH in 1 CARTON (58790-000-24) / 4 APPLICATOR in 1 POUCH / 19.2 mL in 1 APPLICATOR 1995-01-01 Active
58790-0000-30 6 POUCH in 1 CARTON (58790-000-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL 2018-12-07 Active
58790-0000-32 8 POUCH in 1 CARTON (58790-000-32) / 4 APPLICATOR in 1 POUCH / 19.2 mL in 1 APPLICATOR 1995-01-01 Active

Pack size FAQ

What quantity is in NDC 58790-0000-24?
NDC 58790-0000-24 is listed by the FDA — 6 pouch in 1 carton / 4 applicator in 1 pouch / 19.2 ml in 1 applicator.
What NDC number is used to bill for this package of TheraTears Lubricant carboxymethylcellulose sodium 2.5 mg/mL Solution/ Drops?
Bill NDC 58790-0000-24 — the 11-digit billing format is 58790000024. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 58790-000-24, 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: 58790-0000-24, written without dashes as 58790000024. 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 58790-0000-24, the first segment (58790) is the labeler code FDA assigned to MEDTECH PRODUCTS INC; the middle segment (0000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) 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 MEDTECH PRODUCTS 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 4 other package presentations of this same product, including 5 pouches (58790-0000-20), 6 pouches (58790-0000-00), 6 pouches (58790-0000-30). 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?
MEDTECH PRODUCTS 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 33 words ▾

Uses As a lubricant to relieve dryness of the eye. As a protectant against further irritation of the eye. For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

⏱️ Dosage and Administration 18 words ▾

Directions To open, twist tab completely off. Instill 1 or 2 drops in the affected eye(s) as needed.

⚠️ Warnings 124 words ▾

Warnings For external use only To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard.

Use individual vials within 90 days of opening foil pouch. This product contains no preservatives. Any solution not used immediately after opening should be discarded.

Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling. Do not use 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.

Condition worsens or persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 9 words ▾

Active ingredient (In each unit dose) Sodium Carboxymethylcellulose 0.25%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients boric acid , calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium phosphate, water

🎯 Purpose 3 words ▾

Purpose Eye lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58775-0011-00 · Fersinsa 58790-0001-15 · MEDTECH →
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.