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Cystex Plus methenamine, sodium salicylate 162 mg; 162.5 mg Tablet, 40-count — NDC 69693-0512-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cystex Plus methenamine, sodium salicylate 162 mg; 162.5 mg Tablet, 40-count — NDC 69693-512-40 (Billing 69693-0512-40)

by Clarion Brands, LLC · 1 BLISTER PACK in 1 CARTON / 40 TABLET in 1 BLISTER PACK

This is a package of 40 tablets of Cystex Plus methenamine, sodium salicylate 162 mg; 162.5 mg Tablet from Clarion Brands, LLC, marketed since Nov 2015 and currently FDA-listed.

NDC 69693-0512-40
🏷️ FDA NDC (as labeled) 69693-512-40 billing pads the product segment with a zero
This package
Contains40-count Pack sizes4 compare ↓
Product page 69693-0512-20 Also comes in: 20 tablets 69693-512-20 24 tablets 69693-512-24 48 tablets 69693-512-48
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Past resolved recalls for this product (1)
Class II · Jan 24, 2022 · Terminated — cGMP deviations (Ultra Seal Corporation) · FDA recall D-0471-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69693-512-40
Product NDC 69693-512
11-digit billing NDC 69693051240
RxCUI 1489932, 1489934
UNII J50OIX95QV, WIQ1H85SYP
UPC 0889476512480
SPL Set ID 62200228-be42-1cda-9493-02bb491537c8
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-01
Route ORAL
Dosage form TABLET
Substance METHENAMINE; SODIUM SALICYLATE
Quick answers
  • RxCUI (RxNorm): 1489932
Why two NDCs? The FDA registers this code as 69693-512-40 — 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 → 69693-0512-40. 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 Other antibacterials class.

Drug family (ATC) Other antibacterials
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

🧪 What is this product?

Cystex Plus is an unapproved oral tablet containing methenamine and sodium salicylate. Methenamine is typically used in urinary tract products because it converts to formaldehyde in acidic urine, which functions as an antimicrobial agent. Sodium salicylate is a nonsteroidal anti-inflammatory ingredient commonly used for pain and inflammation relief. This product is marketed without FDA approval.

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 eachPer 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: 20 tablets 24 tablets 48 tablets
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
69693-0512-20 69693-512-20 Main listing 1 BLISTER PACK in 1 CARTON / 20 TABLET in 1 BLISTER PACK 2016-05-01 — Active
69693-0512-24 69693-512-24 1 BLISTER PACK in 1 CARTON / 24 TABLET in 1 BLISTER PACK 2022-06-01 — Active
69693-0512-40 You're viewing this 1 BLISTER PACK in 1 CARTON / 40 TABLET in 1 BLISTER PACK 2016-05-01 — Active
69693-0512-48 69693-512-48 1 BLISTER PACK in 1 CARTON / 48 TABLET in 1 BLISTER PACK 2022-06-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 40-count package — 1 blister pack in 1 carton / 40 tablet in 1 blister pack.
How does this package differ from NDC 69693-0512-20?
Both are Cystex Plus methenamine, sodium salicylate 162 mg; 162.5 mg Tablet — the drug itself is identical. This page's package is the 40-count one, while NDC 69693-0512-20 is the 20 tablets package.
What NDC number is used to bill for this package of Cystex Plus methenamine, sodium salicylate 162 mg; 162.5 mg Tablet?
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
Good Neighbor Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 46122-0622-62 AmerisourceBergen 24 tablets $0.176 — Availability likely —
URO-PAIN Dual Action Antibacterial Protection 162 mg/1; 162.5 mg 57237-0332-42 Rising 24 tablets $0.176 — Availability likely —
Walgreens Pain Relief plus UTI Bacteria Control 162 mg/1; 162.5 mg 00363-1277-48 Walgreen 48 tablets — — FDA listed —
Walgreens Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 00363-4404-24 Walgreen 24 tablets — — FDA listed —
Preferred Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 10956-0763-24 Reese 24 tablets — — FDA listed —
Rite Aid Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 11822-4892-04 Rite 24 tablets — — FDA listed —
TopCare Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 36800-0314-24 Topco 24 tablets — — FDA listed —
Meijer Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 41250-0557-24 Meijer 24 tablets — — FDA listed —
Azo Urinary Tract Defense Antibacterial Protection 162 mg/1; 162.5 mg 49973-0011-18 i-Health, 18 tablets — — FDA listed —
Cvs Dual Action Pain Relief 162 mg/1; 162.5 mg 51316-0777-48 CVS 48 tablets — — FDA listed —
Quality Choice Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 63868-0187-24 Chain 24 tablets — — FDA listed —
Premier Value Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 68016-0003-24 Chain 24 tablets — — FDA listed —
Cystex Plus 162 mg/1; 162.5 mgthis 69693-0512-40 Clarion 40 tablets — — FDA listed —
Cystex 162 mg/1; 162.5 mg 69693-0513-24 Clarion 24 tablets — — FDA listed —
Cystex 162 mg/1; 162.5 mg 69693-0518-24 Clarion 24 tablets — — FDA listed —
CVS Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 69842-0314-24 CVS 24 tablets — — FDA listed —
Uti Infection Control 162 mg/1; 162.5 mg 73436-1221-02 CADENCE 12 tablets — — FDA listed —
Quality Choice Antibacterial Plus Urinary Pain Relief 162 mg/1; 162.5 mg 83324-0198-24 Chain 24 tablets — — FDA listed —
Gencare-Urinary Tract Defense 162 mg/1; 162.5 mg 72090-0065-01 PIONEER 48 tablets — — FDA listed —
Nuvicare-Urinary Tract Defense 162 mg/1; 162.5 mg 84324-0041-01 NUVICARE 24 tablets — — 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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color red
ShapeRound
ImprintCYSTEX
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesbenzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl titanium dioxide, triethyl citrate

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

LabelerClarion Brands, LLC
Labeler code69693
First marketedNov 2015
Product typeHuman Otc Drug
Portfolio25 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Uses temporarily relieves pain & burning frequency and urgency of urination

⏱️ Dosage and Administration 47 words ▾

Directions Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Children under 12 years: ask a doctor. Do not use for more than a 3 day period unless directed by a doctor.

⚠️ Warnings 126 words ▾

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if you are 60 or older have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed

📦 Storage and Handling 20 words ▾

Other information each tablet contains: sodium 24.4 mg store at 59-86°F (15-30°C) in a cool dry place protect from sunlight

🧪 Active Ingredient 22 words ▾

Active ingredients (in each tablet) Purposes Methenamine 162 mg Antibacterial Sodium Salicylate 162.5 mg (NSAID)* Analgesic (Pain Reliever) * nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients benzoic acid, croscarmellose sodium, fd&c red #40, fd&c yellow #6, hypromellose , magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl titanium dioxide, triethyl citrate

📄 Do Not Use 11 words ▾

Do not use if you are allergic to salicylates (including aspirin)

📄 Ask a Doctor Before Use If 52 words ▾

Ask a doctor before use if you have frequent, burning urination for the first time the stomach bleeding warning applying to you history of stomach problems, such as heartburn high blood pressure heart disease liver cirrhosis bleeding problems diuretic use ulcers kidney disease a sodium restricted diet reach age 60 or older

📄 Ask a Doctor or Pharmacist Before Use If 31 words ▾

Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or non-prescription) taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug

📄 When Using This Product 12 words ▾

When using this product do not take more than the recommended dosage

📄 Stop Use and Ask a Doctor If 47 words ▾

Stop use and ask a doctor if product has been used for 3 days ringing in the ears you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain or upset that gets worse or lasts

🤰 If Pregnant or Breast-Feeding 53 words ▾

If pregnant or breast feeding ask a health professional before use. It is especially important not to use this product (which contains sodium salicylate) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 23 words ▾

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-844-297-8394

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL VALUE SIZE! 2x More Tablets ‡ MAX STRENGTH Cystex ® Methenamine 162 mg ANTIBACTERIAL ∣ Sodium Salicylate 162.5 mg (NSAID) PAIN RELIEVER UTI PAIN RELIEF + UTI BACTERIA CONTROL Fast relief of pain & burning plus helps control UTI bacteria Maximum Strength UTI Pain Relief Formulated without Urine Discoloring Ingredients † #1 OTC Ingredient for UTI Bacteria Control* † Does not contain urine coloring agents as found in other leading UTI products ‡ Compared to 2023 leading UTI Relief Brands 48 Tablets Cystex is not intended to replace a doctor's care.

TAMPER EVIDENT: TABLETS SEALED IN BLISTER. DO NOT USE IF BLISTER IS OPENED OR DAMAGED . 1000221 REV 7/23 CSTX048BRI MAX STRENGTH Cystex ® Urinary Health Made Eas y™ For more information on Cystex UTI Pain Relief, other products, or Urinary Tract Infections (UTIs) please visit www.cyxtex.com or call 844-297-8394 MAX STRENGTH Cystex ® Urinary Health Made Eas y™ Distributed by: Cystex, LLC 811 Broad Street, Suite 600 Chattanooga, TN 37402 @2023 *Source: IRI Sales Data, 2023 P16919 48ct.

Knockout for Expiration Date and Lot Number Principal Display for Blister Pack CYSTEX Methenamine 162 mg / Sodium Salicylate 162.5 mg (NSAID) URINARY PAIN RELIEF TABLETS Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if you: ■ are age 60 or older ■ have stomach ulcers or bleeding problems ■ take a blood thinner (anticoagulant) or steroid drug ■ take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed. ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN LOT: X00X000 EXP: MM/YY CYSTEX, LLC. 1-844-297-8394 1000075 Carton Label Blister Pack

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 Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Clarion Brands, LLC. 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 3 other package presentations of this same product, including 20 tablets (69693-0512-20), 24 tablets (69693-0512-24), 48 tablets (69693-0512-48). 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?
Clarion Brands, 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.
← 69693-0426-25 · Clarion 69693-0513-24 · Clarion →
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.