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CETAFEN COUGH and COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, 100 mg; 5 mg; 325 mg; 10 mg Tablet, Film Coated — NDC 50332-0141-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CETAFEN COUGH and COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, 100 mg; 5 mg; 325 mg; 10 mg Tablet, Film Coated — NDC 50332-0141-7 (Billing 50332-0141-07)

by HART Health · 100 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET

This is a package of CETAFEN COUGH and COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, 100 mg; 5 mg; 325 mg; 10 mg Tablet, Film Coated from HART Health, marketed since Jan 2023 and currently FDA-listed.

NDC 50332-0141-07
🏷️ FDA NDC (as labeled) 50332-0141-7 billing pads the package segment with a zero
This package
Contains2 tablet, film coated in 1 packet Pack sizes3 compare ↓
Product page 50332-0141-03 Also comes in: 2 tablets 50332-0141-3 2 tablets 50332-0141-4
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50332-0141-7
Product NDC 50332-0141
11-digit billing NDC 50332014107
RxCUI 1098435
UNII 495W7451VQ, 04JA59TNSJ, 362O9ITL9D, 9D2RTI9KYH
Application # M
SPL Set ID 44da0d8c-4a12-4122-99da-781e2809e1a8
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 2023-01-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Quick answers
  • RxCUI (RxNorm): 1098435
Why two NDCs? The FDA registers this code as 50332-0141-7 — a 5-4-1 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 package segment → 50332-0141-07. 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

🧪 What is this product?

Cetafen Cough and Cold is an oral film-coated tablet sold as an over-the-counter monograph product. It combines four active ingredients: acetaminophen, typically used to reduce fever and relieve minor aches and pain; dextromethorphan, commonly used to suppress cough; phenylephrine, typically used as a nasal decongestant; and guaifenesin, commonly used as an expectorant to help thin mucus. This combination product is intended for people seeking to address multiple cold and cough symptoms at once.

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 2 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
50332-0141-03 50332-0141-3 Main listing 20 PACKET in 1 BAG / 2 TABLET, FILM COATED in 1 PACKET 2023-01-09 — Active
50332-0141-04 50332-0141-4 40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET 2023-01-09 — Active
50332-0141-07 You're viewing this 100 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET 2023-01-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 100 packet in 1 box / 2 tablet, film coated in 1 packet.
What NDC number is used to bill for this package of CETAFEN COUGH and COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, 100 mg; 5 mg; 325 mg; 10 mg Tablet, Film Coated?
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
Physicians Care Non-Drowsy Cold and Cough 325 mg/1; 10 mg/1; 5 mg/1; 100 mg 00924-0142-01 Acme 2 tablets — — FDA listed —
Head Congestion and Flu Severe Relief 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 11822-5462-09 Rite 10 tablets — — FDA listed —
Sedalmex XL Flu 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 27854-0350-01 Belmora 12 tablets — — FDA listed —
Head Congestion plus Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 36800-0474-02 TOPCO 12 tablets — — FDA listed —
Head Congestion plus Flu Severe 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 37808-0574-02 HEB 12 tablets — — FDA listed —
Head Congestion plus Flu Severe 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 41163-0713-02 United 12 tablets — — FDA listed —
head congestion plus flu severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 41250-0574-02 MEIJER 12 tablets — — Discontinued —
Multi-Symptom Cold Relief 10 mg/1; 100 mg/1; 325 mg/1; 5 mg 47682-0047-80 Unifirst 2 tablets — — FDA listed —
Medique Decorel Forte 5 mg/1; 325 mg/1; 10 mg/1; 100 mg 47682-0435-36 Unifirst 2 tablets — — FDA listed —
Medique at Home Decorel Forte 100 mg/1; 10 mg/1; 5 mg/1; 325 mg 47682-0735-33 Unifirst 2 tablets — — FDA listed —
Medi-First Cough Cold 5 mg/1; 325 mg/1; 10 mg/1; 100 mg 47682-0835-36 Unifirst 2 tablets — — FDA listed —
Medi-First Plus Cough Cold 100 mg/1; 5 mg/1; 325 mg/1; 10 mg 47682-0836-36 Unifirst 2 tablets — — FDA listed —
CETAFEN COUGH and COLD 100 mg/1; 5 mg/1; 325 mg/1; 10 mgthis 50332-0141-07 HART 2 tablets — — FDA listed —
SUDAFED PE Head Congestion Plus Flu Severe 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 50580-0450-01 Kenvue 12 tablets — — FDA listed —
Head Congestion Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 50804-0274-02 GOODSENSE 12 tablets — — FDA listed —
Sinus PE Head Congestion and Flu Severe 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 51316-0546-08 CVS 12 tablets — — FDA listed —
Head Congestion plus Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 53943-0274-02 DISCOUNT 12 tablets — — FDA listed —
Head Congestion Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 63868-0102-24 CHAIN 12 tablets — — FDA listed —
Head Congestion plus Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 63941-0274-02 VALU 12 tablets — — FDA listed —
Head Congestion plus Flu Severe PE 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 72036-0274-02 HARRIS 12 tablets — — FDA listed —
Head Congestion Plus Flu Severe Pe 325 mg/1; 10 mg/1; 100 mg/1; 5 mg 72476-0174-02 RETAIL 12 tablets — — FDA listed —
Thompson Cough and Cold Multi-Symptom Relief 100 mg/1; 5 mg/1; 325 mg/1; 10 mg 73408-0835-80 Thompson 2 tablets — — FDA listed —
Cold Terminator Cold Relief 5 mg/1; 325 mg/1; 10 mg/1; 100 mg 84269-2556-01 Wildman 2 tablets — — FDA listed —
Medique at Home Decorel Forte 100 mg/1; 10 mg/1; 5 mg/1; 325 mg 85766-0174-01 Sportpharm 2 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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 orange
ShapeCapsule
Imprint44;546
Size17 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 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 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

The official label also statesInactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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

LabelerHART Health
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code50332
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio36 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

Uses Temporarily relieves these cold and flu symptoms cough sore throat headache minor aches and pains nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and bronchial secretions to coughs more productive Temporarily reduces fever

⏱️ Dosage and Administration 51 words ▾

Directions Do not take more than directed Adults and children 12 years of age and over take 2 caplets every 6 to 8 hours while symptoms persist do not take more than 8 caplets in 24 hours unless directed by a doctor Children under 12 years of age: ask a doctor

⚠️ Warnings 85 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing 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 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 a doctor right away.

🆘 Overdosage 50 words ▾

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

🧪 Active Ingredient 19 words ▾

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 100 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 72 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription) if you have ever had an allergic reaction to this product or any of its ingredients 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, or if you do not know if your prescription drug contains an MAOI

📄 Ask a Doctor Before Use If 50 words ▾

Ask a doctor before use if you have heart, liver, or thyroid disease high blood pressure diabetes glaucoma trouble urinating due to an enlarged prostate a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 28 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin you do not know if other drugs you are taking contain acetaminophen

📄 Stop Use and Ask a Doctor If 70 words ▾

Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away redness or swelling is present you get nervous, dizzy, or sleepless new symptoms occur fever worsens or lasts more than 3 days pain, nasal congestion, or cough worsens or lasts more than 7 days cough comes back or occurs with a rash or headache that lasts 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 6 words ▾

Keep out of reach of children.

📄 Other Information 29 words ▾

Other information: caplets enclosed in a sealed packet do not use if packet is torn, cut or open store at 59° to 86°F (15°-30°C) avoid excessive heat and humidity

📄 Package Label / Principal Display Panel 1 words ▾

CetafenCough.jpg

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
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 HART Health. 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 2 other package presentations of this same product, including 2 tablets (50332-0141-03), 2 tablets (50332-0141-04). 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?
HART Health 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.
← 50332-0139-03 · HART 50332-0144-04 · HART →
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.