Refresh Tears Lubricant CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL Solution/ Drops, 3 mL — NDC 67751-130-01 (Billing 67751-0130-01)
by Navajo Manufacturing Company Inc. · 3 mL in 1 BOTTLE, DROPPER
This is a package of 3 mL of Refresh Tears Lubricant CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL Solution/ Drops from Navajo Manufacturing Company Inc., no longer marketed (first marketed Sep 2004), no longer in the FDA NDC Directory. It is this product's only package size.
NDC 67751-0130-01
🏷️ FDA NDC (as labeled)
67751-130-01
billing pads the product segment with a zero
🗂️ 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 67751-130-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 67751 labeler · 130 product · 01 package
- Package marketed since
- Dec 22, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6775113001 2
- FDA record last changed
- Jul 24, 2026
⚠️
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 · Aug 20, 2026 — Lack of Assurance of Sterility (Sterling Pharmaceutical Services LLC) · FDA recall D-0860-2026
Class II · Aug 20, 2026 — Lack of Assurance of Sterility (Sterling Pharmaceutical Services LLC) · FDA recall D-0863-2026
Class II · Aug 20, 2026 — Lack of Assurance of Sterility (Sterling Pharmaceutical Services LLC) · FDA recall D-0855-2026
Class II · Aug 20, 2026 — Lack of Assurance of Sterility (Sterling Pharmaceutical Services LLC) · FDA recall D-0858-2026
Class II · Aug 20, 2026 — Lack of Assurance of Sterility (Sterling Pharmaceutical Services LLC) · FDA recall D-0857-2026
Class II · Apr 23, 2025 — cGMP deviations and lack of assurance of sterility. (BRS Analytical Services, LLC) · FDA recall D-0406-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
67751-130-01
Product NDC
67751-130
11-digit billing NDC
67751013001
RxCUI
1188426
UNII
K679OBS311
Application #
M018
SPL Set ID
3b94f67c-d675-4e16-846a-3ca39b0405e0
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Dec 2025)
Marketing start
2004-09-01
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
CARBOXYMETHYLCELLULOSE SODIUM
Quick answers
- RxCUI (RxNorm): 1188426
Why two NDCs?
The FDA registers this code as 67751-130-01 — 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 → 67751-0130-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
🧪 What is this product?
Refresh Tears Lubricant is an over-the-counter eye drop solution containing carboxymethylcellulose sodium, a lubricating agent. It is typically used to provide moisture and relief to dry or irritated eyes by forming a protective film on the eye surface. This product is marketed under the FDA's OTC monograph rules for artificial tear and lubricant eye drops. The drops are applied directly to the eye as needed for temporary comfort.
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about CARBOXYMETHYLCELLULOSE SODIUM?
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.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 67751-0130-01 You're viewing this Main listing | 3 mL in 1 BOTTLE, DROPPER | 2017-12-22 | — | Discontinued by firm |
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 | $0.163 | — | Availability likely | — |
| Rugby Lubricant Eye Drops .5 g/100mL 00536-1387-92 | Rugby | 30 vials | $0.227 | — | Availability likely | — |
| Good Neighbor Pharmacy Lubricant Eye Drops .5 g/100mL 46122-0756-56 | Amerisource | 30 vials | $0.227 | — | Availability likely | — |
| carboxymethylcellulose sodium 5 mg/mL 50268-0067-30 | AvPAK | 30 vials | $0.227 | — | Availability likely | — |
| Foster and Thrive Lubricant Eye Drops .5 g/100mL 70677-1190-01 | Strategic | 30 vials | $0.227 | — | Availability likely | — |
| Carboxymethylcellulose Sodium Eye Lubricant 5 mg/mL 42494-0448-05 | Cameron | 2 bottles | $0.275 | — | Discontinued | — |
| Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops .5 g/100mL 00536-1386-35 | Rugby | 2 bottles | $0.280 | — | Availability likely | — |
| carboxymethylcellulose sodium 5 mg/mL 50268-0068-15 | AvPAK | 1 bottle | $0.324 | — | Availability likely | — |
| Leader Lubricant Eye Drops Soothing Relief .5 g/100mL 70000-0705-01 | LEADER/Cardinal | 1 bottle | $0.324 | — | 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 | — | — | Discontinued | — |
| 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/mLthis 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/mL 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2004
On the market since
Sep 2004
📍
2026
Currently FDA-listed
22 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerNavajo Manufacturing Company Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code67751
First marketedSep 2004
Product typeHuman Otc Drug
Portfolio60 products on file
More NDCs from Navajo Manufacturing Company Inc. labeler code 67751
- Colgate Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE 1 mg/g Paste, Dentifrice NDC 67751-118-01
- Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine 250 mg; 250 mg; 65 mg Tablet, Film Coated NDC 67751-119-01
- Motrin IB IBUPROFEN 200 mg Tablet, Film Coated NDC 67751-120-01
- Crest Cavity Protection Regular Sodium Fluoride 1.5 mg/g Paste, Dentifrice NDC 67751-124-01
- Flanax Pain Reliever/Fever Reducer Naproxen Sodium 220 mg Tablet NDC 67751-125-01
- Bayer Genuine Aspirin 325 mg Tablet NDC 67751-129-01
- HANDY SOLUTIONS DOVE COOL ESSENTIAL CUCUMBER AND GREEN TEA SCENT ANTI-PERSPIRANT Aluminum Zirconium Tetrachlorohydrex GLY 14.8 g/100g Stick NDC 67751-134-01
- Aleve naproxen sodium 220 mg Tablet NDC 67751-144-01
- Midol ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE 500 mg; 60 mg; 15 mg Tablet NDC 67751-145-01
- Advil IBUPROFEN 200 mg Tablet, Coated NDC 67751-146-01
- Advil PM DIPHENHYDRAMINE CITRATE, IBUPROFEN 38 mg; 200 mg Tablet, Coated NDC 67751-147-01
- Advil Liquigels IBUPROFEN 200 mg Capsule, Liquid Filled NDC 67751-148-02
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. May be used as a protectant against further irritation.
⏱️ Dosage and Administration ▾
Directions Instill 1 or 2 drops in the affected eye(s) as needed.
⚠️ Warnings ▾
Warnings For external use only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If solution changes color or becomes cloudy, do not use.
📦 Storage and Handling ▾
Other information Use only if the imprinted seal around the bottle neck is intact and not damaged. Use before expiration date marked on container. Store at 59° - 86° F (15° - 30 C) RETAIN THIS PACKAGING FOR FUTURE REFERENCE.
🧪 Active Ingredient ▾
Active ingredient Carboxymethylcellulose sodium 0.5%
🧪 Inactive Ingredients ▾
Inactive ingredients Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; PURITE ® (stablilized oxychloro complex); sodium borate; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
🎯 Purpose ▾
Purpose Eye lubricant
📄 Stop Use and Ask a Doctor If ▾
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.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? 1.800.433.8871, M-F 6 AM - 4:30 PM Pacific Time refreshbrand.com
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Refresh Tears
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 CARBOXYMETHYLCELLULOSE SODIUM — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 24%
Female · 76%
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
No longer marketed (per FDA listing data)
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) | — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Navajo Manufacturing Company 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.
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.