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Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg; 120 mg Tablet, Extended Release — NDC 58602-0816-72 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg; 120 mg Tablet, Extended Release — NDC 58602-816-72 (Billing 58602-0816-72)

by Aurohealth LLC · 3 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg; 120 mg Tablet, Extended Release from Aurohealth LLC, marketed since Jun 2022 and currently FDA-listed.

NDC 58602-0816-72
🏷️ FDA NDC (as labeled) 58602-816-72 billing pads the product segment with a zero
This package
Contains8 tablet, extended release in 1 blister pack Pack sizes3 compare ↓
Product page 58602-0816-67 Also comes in: 10 tablets 58602-816-67 10 tablets 58602-816-83
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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 58602-816-72 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58602 labeler · 816 product · 72 package
Package marketed since
Feb 12, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5860281672 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-816-72
Product NDC 58602-816
11-digit billing NDC 58602081672
RxCUI 1367426
UNII 9TN87S3A3C, 6V9V2RYJ8N
Application # ANDA211360
SPL Set ID 638a9664-4129-46fd-9ba1-d660a7366c9f
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug; alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1367426
Why two NDCs? The FDA registers this code as 58602-816-72 — 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 → 58602-0816-72. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Propionic acid derivatives, Antiinflammatory products for vaginal administration, Antiinflammatory preparations, non-steroids for topical use
How it works Cyclooxygenase Inhibitors
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

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: 10 tablets 10 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
58602-0816-67 58602-816-67 Main listing 2 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2022-06-01 — Active
58602-0816-83 58602-816-83 1 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2022-06-01 — Active
58602-0816-72 You're viewing this 3 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2025-02-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg; 120 mg Tablet, Extended Release?
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
Leader All Day Sinus and Cold D 220 mg/1; 120 mg 70000-0605-01 Cardinal 1 tablet $0.244 — Availability likely —
Aleve-D Sinus and Headache 220 mg/1; 120 mg 00280-6045-10 Bayer 10 tablets — — FDA listed —
Aleve-D Sinus and Cold 120 mg/1; 220 mg 00280-6090-10 Bayer 10 tablets — — FDA listed —
All Day Sinus and Cold D 220 mg/1; 120 mg 00363-0650-01 Walgreen 1 tablet — — FDA listed —
Topcare Sinus and Cold D 220 mg/1; 120 mg 36800-0417-01 Topco 1 tablet — — FDA listed —
Sinus and Cold D 220 mg/1; 120 mg 41250-0417-01 Meijer 1 tablet — — FDA listed —
Sudafed Sinus 12 Hour Pressure plus Pain 220 mg/1; 120 mg 50580-0434-01 Kenvue 8 tablets — — FDA listed —
Sinus and Cold D 220 mg/1; 120 mg 51316-0339-01 CVS 1 tablet — — FDA listed —
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1; 120 mgthis 58602-0816-72 Aurohealth 8 tablets — — FDA listed —
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache 220 mg/1; 120 mg 58602-0832-67 Aurohealth 10 tablets — — FDA listed —
Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus 220 mg/1; 120 mg 71179-0816-24 VESPYR 8 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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
ShapeCapsule
ImprintL95
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 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII Z78RG6M2N2
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the 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.
  • 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 statesColloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and 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

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA211360 (ANDA)
Labeler code58602
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio178 products on file

More NDCs from Aurohealth LLC labeler code 58602

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

⏱️ Dosage and Administration 59 words ▾

Directions do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use

⚠️ Warnings 154 words ▾

Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

📦 Storage and Handling 26 words ▾

Other information each caplet contains: sodium 22 mg store at 20° to 25°C (68° to 77°F) store in a dry place Meets USP dissolution test 3.

🧪 Active Ingredient 23 words ▾

Active ingredients (in each caplet) Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine Hydrochloride USP 120 mg, extended-release *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

🎯 Purpose 6 words ▾

Purposes Pain reliever/fever reducer Nasal decongestant

📄 Do Not Use 82 words ▾

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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. in children under 12 years of age

📄 Ask a Doctor Before Use If 70 words ▾

Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers

📄 Ask a Doctor or Pharmacist Before Use If 37 words ▾

Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug

📄 When Using This Product 13 words ▾

When using this product take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 105 words ▾

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling redness or swelling is present in the painful area any new symptoms appear fever gets worse or lasts more than 3 days you have difficulty swallowing or the caplet feels stuck in your throat you get nervous, dizzy, or sleepless nasal congestion lasts more than 7 days

🤰 If Pregnant or Breast-Feeding 48 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 22 words ▾

Keep out of 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 28 words ▾

Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India

📄 Package Label / Principal Display Panel 84 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 10 Caplets (Capsule-Shaped Tablets) Blister Carton Label NDC 58602-816-83 *Compare to active ingredients in Aleve-D ® Sinus & Cold Naproxen Sodium and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 220 mg/120 mg Non-Drowsy THIS CARTON IS NOT CHILD RESISTANT Pain Reliever/Fever Reducer (NSAID) Nasal Decongestant SINUS & COLD 12 Hour Multi-Symptom Relief of Sinus Pressure Headache Sinus Congestion Nasal Congestion Body Aches 10 Caplets (1 x 10's blister) AUROHEALTH 1 Caplet - 12 Hours Naproxen Figure

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 Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold (this brand).

Top reported reactions

Pain12
Cholecystitis Chronic9
Injury7
Pulmonary Embolism7
Abdominal Pain Upper6
Gallbladder Disorder6
Abdominal Pain5

Age at onset

Elderly1

Reporter sex

37 reports
Male · 8%
Female · 92%

Serious outcomes

Hospitalization15
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 0
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

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 Aurohealth 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 2 other package presentations of this same product, including 10 tablets (58602-0816-67), 10 tablets (58602-0816-83). 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?
Aurohealth 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.
← 58602-0815-74 · Aurohealth 58602-0817-02 · Aurohealth →
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.