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Pentrexcilina Daytime Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 10 mg; 4 mg; 500 mg Tablet, 6-count — NDC 69729-223-06 (Billing 69729-0223-06)

by OPMX LLC · 3 POUCH in 1 CARTON / 2 TABLET in 1 POUCH

This is a package of 6 tablets of Pentrexcilina Daytime Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 10 mg; 4 mg; 500 mg Tablet from OPMX LLC, marketed since Dec 2020 and currently FDA-listed.

NDC 69729-0223-06
🏷️ FDA NDC (as labeled) 69729-223-06 billing pads the product segment with a zero
This package
Contains6-count Pack sizes5 compare ↓
Product page 69729-0223-02 Also comes in: 2 tablets 69729-223-02 12 tablets 69729-223-37 100 tablets 69729-223-50 144 tablets 69729-223-38
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 69729-223-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69729 labeler · 223 product · 06 package
Package marketed since
Jan 10, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0810053181263, 0856828008243, 0856828008250, 0856828008144
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69729-223-06
Product NDC 69729-223
11-digit billing NDC 69729022306
RxCUI 2463332
UNII 04JA59TNSJ, V1Q0O9OJ9Z, 362O9ITL9D
UPC 0810053181263, 0856828008243, 0856828008250, 0856828008144
Application # M012
SPL Set ID b7b3c15a-bb28-5c25-e053-2a95a90ad3b1
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-30
Route ORAL
Dosage form TABLET
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 2463332
Why two NDCs? The FDA registers this code as 69729-223-06 — 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 → 69729-0223-06. 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 Anilides class.

Drug family (ATC) Anilides
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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

Pentrexcilina Daytime is an oral tablet that combines three active ingredients to address symptoms commonly associated with colds and minor respiratory discomfort. Acetaminophen is typically used to reduce fever and relieve mild pain, while chlorpheniramine maleate is a first-generation antihistamine commonly used to help manage allergy-related symptoms such as itching and sneezing. Phenylephrine hydrochloride is a decongestant typically used to help reduce nasal congestion. This is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for its drug category rather than through an individual product application.

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: 2 tablets 12 tablets 100 tablets 144 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
69729-0223-06 You're viewing this 3 POUCH in 1 CARTON / 2 TABLET in 1 POUCH 2024-01-10 — Active
69729-0223-37 69729-223-37 6 POUCH in 1 CARTON / 2 TABLET in 1 POUCH 2024-01-10 — Active
69729-0223-38 69729-223-38 72 POUCH in 1 CARTON / 2 TABLET in 1 POUCH 2020-12-30 — Active
69729-0223-02 69729-223-02 Main listing 2 TABLET in 1 POUCH 2020-12-30 — Active
69729-0223-50 69729-223-50 50 POUCH in 1 CARTON / 2 TABLET in 1 POUCH 2020-12-30 — Active

Pack size FAQ

What quantity is in this package?
This is a 6-count package — 3 pouch in 1 carton / 2 tablet in 1 pouch.
How does this package differ from NDC 69729-0223-02?
Both are Pentrexcilina Daytime Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 10 mg; 4 mg; 500 mg Tablet — the drug itself is identical. This page's package is the 6-count one, while NDC 69729-0223-02 is the 2 tablets package.
What NDC number is used to bill for this package of Pentrexcilina Daytime Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 10 mg; 4 mg; 500 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
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg/1; 4 mg/1; 10 mg 69729-0122-37 OPMX 12 tablets — — FDA listed —
Coldtac Ultra 10 mg/1; 500 mg/1; 4 mg 69729-0133-06 OPMX 6 tablets — — FDA listed —
Pentrexcilina Daytime 10 mg/1; 4 mg/1; 500 mgthis 69729-0223-06 OPMX 6 tablets — — FDA listed —
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg/1; 4 mg/1; 10 mg 69729-0322-27 OPMX 2 tablets — — FDA listed —
Resfriol D 10 mg/1; 500 mg/1; 4 mg 69729-0323-27 OPMX 2 tablets — — FDA listed —
Desenfriol D 500 mg/1; 4 mg/1; 10 mg 69729-0829-30 OPMX 30 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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 white
ShapeRound
ImprintA15
Size13 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 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.

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

The official label also statesInactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

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

LabelerOPMX LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedDec 2020
Product typeHuman Otc Drug
Portfolio87 products on file

More NDCs from OPMX LLC labeler code 69729

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 🎯 Purpose 📄 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 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

⏱️ Dosage and Administration 64 words ▾

Directions: Do not take more than directed - see overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

If pregnant or breast-feeding: ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 37 words ▾

Other information: Store at room temperature between 20-25°C (68-77ºF): excursions permitted between 15°C-30°C (59°F-86°F) Avoid excessive heat and humidity Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering

🧪 Active Ingredient 16 words ▾

ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

🎯 Purpose 7 words ▾

PURPOSE Pain Reliever/Fever Reducer Antihistamine Nasal decongestant

📄 Do Not Use 100 words ▾

Do not use: with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy

📄 Ask a Doctor Before Use If 35 words ▾

Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 39 words ▾

When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding: ask a health professional before use.

📄 Keep Out of Reach of Children 54 words ▾

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 11 words ▾

Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

📄 Patient Package Insert 44 words ▾

PRINCIPAL DISPLAY PANEL - 2 TABLETS NDC 69729-223-02 PENTREXCILINA Actaminophen 500 mg...........Pain reliever/Fever reducer Chlorpheniramine Maleate 4 mg.........Antihistamine Phenylephrine HCl 10 mg..............Nasal decongestant Effective and Quick Relief from cold & flu symptoms Headache Nasal Congestion Itchy, Watery Eyes Runny Nose & Sneezing ​ PenDTPou

📄 Package Label / Principal Display Panel 213 words ▾

PRINCIPAL DISPLAY PANEL - 144 TABLETS COLD & FLU NDC 69729-223-38 DAYTIME Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg PENTREXCILINA Effective and Quick Relief from cold & flu symptoms Headache Nasal Congestion Itchy, Watery Eyes Runny Nose & Sneezing ​ ​ 144 Tablets (72 Pouches of 2 tablets) PenDT144

PRINCIPAL DISPLAY PANEL - 12 TABLETS COLD & FLU NDC 69729-223-37 DAYTIME Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg PENTREXCILINA Effective and Quick Relief from cold & flu symptoms Headache Nasal Congestion Itchy, Watery Eyes Runny Nose & Sneezing ​12 Tablets (6 Pouches of 2 tablets) PenDT12

PRINCIPAL DISPLAY PANEL - 6 TABLETS COLD & FLU NDC 69729-223-06 DAYTIME Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg PENTREXCILINA Effective and Quick Relief from cold & flu symptoms Headache Nasal Congestion Itchy, Watery Eyes Runny Nose & Sneezing ​6 Tablets (3 Pouches of 2 tablets) PenDT6

PRINCIPAL DISPLAY PANEL 100 TABLETS COLD & FLU NDC 69729-223-50 DAYTIME Actaminophen 500 mg • Chlorpheniramine Maleate 4 mg • Phenylephrine HCl 10 mg PENTREXCILINA® Effective and Quick Relief from cold & flu symptoms Headache Nasal Congestion Itchy, Watery Eyes Runny Nose & Sneezing​ ​100 Tablets (50 packs of 2 tablets) PDP100

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 Pentrexcilina Daytime (this brand).

Top reported reactions

Hypersensitivity1
Urticaria1

Reporter sex

1 reports
Male · 100%

Serious outcomes

Hospitalization1
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
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) ✓ 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 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 OPMX 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 4 other package presentations of this same product, including 2 tablets (69729-0223-02), 12 tablets (69729-0223-37), 100 tablets (69729-0223-50). 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?
OPMX 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.
← 69729-0161-24 · OPMX 69729-0269-53 · OPMX →
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.