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Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid, 118 mL — NDC 50066-0533-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid, 118 mL — NDC 50066-533-24 (Billing 50066-0533-24)

by Genomma Lab USA, Inc. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL; 100 mg/5mL; 5 mg/5mL Liquid from Genomma Lab USA, Inc., marketed since Sep 2013 and currently FDA-listed. It is this product's only package size.

NDC 50066-0533-24
🏷️ FDA NDC (as labeled) 50066-533-24 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 50066-533-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50066 labeler · 533 product · 24 package
Package marketed since
Sep 15, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5006653324 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50066-533-24
Product NDC 50066-533
11-digit billing NDC 50066053324
RxCUI 1044949
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID b9d32964-5bd7-44b0-be98-827d5310ed4f
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-15
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1044949
Why two NDCs? The FDA registers this code as 50066-533-24 — 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 → 50066-0533-24. 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.

RxNorm drug class

This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
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.

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

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

Tukol X-Pecto Miel Multi Symptom Cold is an OTC liquid medicine taken by mouth that combines three active ingredients commonly used in cold and cough products. Dextromethorphan is a cough suppressant typically used to reduce coughing. Guaifenesin is an expectorant, which is commonly used to help thin mucus and make it easier to clear from the airways. Phenylephrine is a nasal decongestant typically used to help relieve nasal congestion and stuffiness associated with colds.

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 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.
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
50066-0533-24 You're viewing this Main listing 118 mL in 1 BOTTLE 2013-09-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70000-0133-01 Cardinal 1 bottle $0.018 — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 70677-1187-01 Strategic 1 bottle $0.019 — FDA listed —
Tussin Multi Symptom Cold CF Adult 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 00904-6537-20 Major 1 bottle $0.021 — Availability likely —
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 83324-0155-04 QUALITY 1 bottle $0.021 — Availability likely —
Robitussin Peak Cold Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 00031-8742-14 Haleon 1 bottle — — FDA listed —
Bactimicina Cough And Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 24286-1546-04 DLC 1 bottle — — FDA listed —
Tukol Honey Children Cough and Congestion 5 mg/2.5mL; 50 mg/2.5mL; 2.5 mg/2.5mL 50066-0301-04 Genomma 1 bottle — — FDA listed —
Tukol Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0504-24 Genomma 118 ml — — FDA listed —
Tukol Cough and Congestion 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 50066-0510-04 Genomma 1 bottle — — FDA listed —
Tukol X-Pecto Miel Multi Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mLthis 50066-0533-24 Genomma 118 ml — — FDA listed —
Tukol Cough And Cold Honey Flavor 100 mg/5mL; 5 mg/5mL; 10 mg/5mL 50066-0534-04 Genomma 1 bottle — — FDA listed —
GoodSense Tussin CF Multi-Symptom Cold, Raspberry 5 mg/5mL; 10 mg/5mL; 100 mg/5mL 50804-0256-04 Geiss, 118 ml — — FDA listed —
Desgen Dm 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 52083-0646-16 Kramer 474 ml — — FDA listed —
Mucosan Multi-Symptom Cherry 10 mg/5mL; 5 mg/5mL; 100 mg/5mL 53145-0693-04 Menper 1 bottle — — FDA listed —
Mucosan Multi-Symptom Honey 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53145-0695-04 Menper 1 bottle — — FDA listed —
Tussin CF Multi-Symptom Cold 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53942-0504-26 DeMoulas 237 ml — — FDA listed —
Tussin CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 53943-0504-26 Discount 237 ml — — FDA listed —
Multi-Symptom Cold 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 55319-0201-36 Family 1 bottle — — FDA listed —
Broncomiel Adults 200 mg/10mL; 10 mg/10mL; 20 mg/10mL 55758-0512-09 Pharmadel 1 bottle — — FDA listed —
Rompe Pecho CF 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 58593-0235-04 Efficient 118 ml — — Discontinued —
Tussin Multi Symptom Cold CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0382-04 Best 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 63941-0823-04 Best 1 bottle — — FDA listed —
Tussin CF Non Drowsy Multi Symptom 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0266-18 WinCo 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0470-04 WinCo 1 bottle — — FDA listed —
Tussin CF 20 mg/10mL; 200 mg/10mL; 10 mg/10mL 67091-0691-04 WinCo 1 bottle — — FDA listed —
Tussin Cf 10 mg/5mL; 100 mg/5mL; 5 mg/5mL 76281-0504-24 AptaPharma 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

FlavorHoney
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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesanhydrous citric acid, FD and C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

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

LabelerGenomma Lab USA, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50066
First marketedSep 2013
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Genomma Lab USA, Inc. labeler code 50066

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

Uses help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold • nasal congestion • cough due to minor throat and bronchial irritation

⏱️ Dosage and Administration 55 words ▾

Directions Do not take more than 6 doses in any 24 hour period This adult strength product is not intended for use in children under 12 years of age Age - adults and children 12 years and over Dose - 2 teaspoons every 4 hours Age - children under 12 Dose - do not use

⚠️ Warnings 56 words ▾

Warnings Do not use 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.

🧪 Active Ingredient 22 words ▾

DRUG FACTSActive ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 5 mg

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients anhydrous citric acid, FD and C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

🎯 Purpose 6 words ▾

Purposes Cough Suppressant Expectorant Nasal Decongestant

📄 Ask a Doctor or Pharmacist Before Use If 76 words ▾

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days, or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 22 words ▾

Other information each teaspoon contains: sodium 3 mg store at 20‐25 ° C (68‐77 ° F). Do not refrigerate. dosage cup provided

📄 Questions or Comments 19 words ▾

Questions or comments? 1 877 99 GENOM (43666) Monday to Friday from 8 am to 6 pm, Central time.

📄 Package Label / Principal Display Panel 99 words ▾

Tukol X-PECTO MIEL Cough & Cold product label Tukol ® X-PECTO MIEL DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL Cough Suppressant / Expectorant / Nasal Decongestant Tukol ® X-PECTO MIEL Cough & Cold Quiets Cough Thins & loosens Phlegm Clears Nasal Congestion NATURAL HONEY FLAFOR Ages / 12+ 4 FL OZ (118 ml) 2000006935 6 50066 00042 0 LOT no. Exp. Distributed by Genomma Lab USA Inc.

Houston TX, 77027 BX-035 Rev. 02 Genomma Lab. ® rege Tokul X-PECTO 533-24 Box VER2 Tokul X-PECTO 533-24 Btl VER2

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 DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Dizziness28
Dyspnoea25
Diarrhoea23
Choking16
Headache16
Insomnia16
Nausea15

Age at onset

Child1
Adult24
Elderly14

Reporter sex

298 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization63
Death10
Life-threatening8
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 29 6
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
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 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 Genomma Lab USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Genomma Lab USA, 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.
← 50066-0525-24 · Genomma 50066-0534-04 · Genomma →
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.