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DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, Extended Release — NDC 58602-618-05 (Billing 58602-0618-05)

by Aurohealth LLC · 1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE

This is a package of DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, Extended Release from Aurohealth LLC, marketed since Apr 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58602-0618-05
🏷️ FDA NDC (as labeled) 58602-618-05 billing pads the product segment with a zero
This package
Contains89 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 58602-618 · Also comes in: 148 mL 58602-618-06
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-618-05
Product NDC 58602-618
11-digit billing NDC 58602061805
RxCUI 1373045
UNII 7355X3ROTS
Application # ANDA218417
SPL Set ID fc328034-ad2a-4f7d-81cf-f4da4e64f5d7
Established class (EPC) Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Sigma-1 Agonist
Mechanism of action Uncompetitive NMDA Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-17
Route ORAL
Dosage form SUSPENSION, EXTENDED RELEASE
Substance DEXTROMETHORPHAN
Quick answers
  • RxCUI (RxNorm): 1373045
Why two NDCs? The FDA registers this code as 58602-618-05 — 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 → 58602-0618-05. 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

📗 Our plain-language guide HelloPharmacist
  • It's a cough suppressant. It temporarily relieves cough from minor throat and bronchial irritation, like with a cold or inhaled irritants. Some products also help you sleep by calm...
  • It depends on the product. Extended-release suspensions like Delsym are labeled for every 12 hours, while Giltuss Honey DM Cough is every 6 to 8 hours with a 4-dose daily limit. Ch...
  • Be careful. Don't use it if you take a prescription MAOI, or within 2 weeks of stopping one. If you're not sure whether your medicine is an MAOI, ask me or your doctor before takin...
  • Nighttime products can cause marked drowsiness, and children may become excitable. Avoid alcohol and be careful driving.
📖 Read our full Dextromethorphan guide →

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.
Try another pack size: 148 mL
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
58602-0618-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE 2026-04-17 — Active
58602-0618-06 58602-618-06 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE 2026-04-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 89 ml in 1 bottle.
What NDC number is used to bill for this package of DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, 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
Good Sense Cough DM 30 mg/5mL 00113-0958-21 L. 1 bottle $0.066 — Availability likely —
cough dm 30 mg/5mL 00904-6312-56 Major 1 bottle $0.066 — Availability likely —
dextromethorphan polistirex extended release 30 mg/5mL 45802-0433-21 Padagis 1 bottle $0.066 — Availability likely —
Good Neighbor Pharmacy Cough DM ER 30 mg/5mL 46122-0141-21 Amerisource 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0187-01 Cardinal 1 bottle $0.066 — Availability likely —
leader childrens cough dm 30 mg/5mL 70000-0195-01 Cardinal 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0302-01 Cardinal 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1025-01 Strategic 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1026-01 Strategic 1 bottle $0.066 — Availability likely —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0173-63 Reckitt 1 bottle $0.102 — FDA listed —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0177-63 Reckitt 1 bottle $0.102 — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8655-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8725-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8726-10 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8753-03 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8754-15 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8755-15 Haleon 1 bottle — — FDA listed —
good sense cough dm 30 mg/5mL 00113-0384-21 L. 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 00363-0384-21 Walgreen 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 00363-0494-21 Walgreen 1 bottle — — Discontinued —
childrens cough dm 30 mg/5mL 00363-0899-21 Walgreen 1 bottle — — FDA listed —
up and up 12 hour cough relief 30 mg/5mL 11673-0114-28 Target 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 11822-0384-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0494-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0958-01 Rite 1 bottle — — Discontinued —
cough dm 30 mg/5mL 17856-6312-01 ATLANTIC 5 ml — — FDA listed —
signature care 12 hour cough relief 30 mg/5mL 21130-0012-21 Safeway 1 bottle — — FDA listed —
Signature Care Cough Relief 30 mg/5mL 21130-0520-21 Safeway 1 bottle — — FDA listed —
Cough Dm 30 mg/5mL 21130-0538-21 Safeway 1 bottle — — FDA listed —
signature care childrens 12 hour cough relief 30 mg/5mL 21130-0890-21 Safeway 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 30142-0384-21 Kroger 1 bottle — — FDA listed —
cough dm 30 mg/5mL 30142-0494-21 Kroger 1 bottle — — FDA listed —
TopCare Cough DM 30 mg/5mL 36800-0494-21 Topco 1 bottle — — FDA listed —
Topcare Cough DM 30 mg/5mL 36800-0552-21 Topco 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 37808-0384-21 H 1 bottle — — FDA listed —
equaline cough dm 30 mg/5mL 41163-0384-21 United 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0384-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0494-28 Meijer 1 bottle — — FDA listed —
cough dm childrens 30 mg/5mL 41250-0899-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0958-28 Meijer 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0384-21 American 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0958-21 American 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0384-21 HyVee 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0494-21 HyVee 1 bottle — — FDA listed —
Equate Cough DM 30 mg/5mL 49035-0384-21 Wal-Mart 1 bottle — — FDA listed —
equate cough dm 30 mg/5mL 49035-0899-28 Wal-Mart 1 bottle — — FDA listed —
Delsym 30 mg/5mL 50090-0224-00 A-S 1 bottle — — FDA listed —
12 Hr Relief Cough Dm 30 mg/5mL 51316-0263-21 CVS 1 bottle — — FDA listed —
Childrens 12 Hr Cough Relief 30 mg/5mL 51316-0429-28 CVS 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0384-21 Dolgencorp 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0958-21 Dolgencorp, 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 56062-0384-21 Publix 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0610-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0611-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0617-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mLthis 58602-0618-05 Aurohealth 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0384-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0709-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0958-21 CVS 1 bottle — — FDA listed —
Delsym 30 mg/5mL 63824-0171-22 Reckitt 1 cello — — FDA listed —
Delsym 30 mg/5mL 63824-0175-22 Reckitt 1 cello — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mL 65162-0700-76 Amneal 1 bottle — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mL 65162-0799-76 Amneal 1 bottle — — FDA listed —
dextromethorphan polistirex extended release 30 mg/5mL 72162-2281-02 Bryant 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0384-28 Amazon.com 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0494-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0899-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0958-28 Amazon.com 1 bottle — — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 applicationANDA218417 (ANDA)
Labeler code58602
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio178 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 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 31 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

⏱️ Dosage and Administration 105 words ▾

Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age 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 15 words ▾

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients citric acid anhydrous, D&C Red no.33, edetate disodium, ethylcellulose, FD & C Blue no. 1, FD & C Red no. 40, grape flavour, high fructose corn syrup, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sucrose, tragacanth, xanthan gum

🎯 Purpose 3 words ▾

Purpose Cough suppressant

📄 Ask a Doctor Before Use If 28 words ▾

Ask a doctor before use if you have chronic cough that lasts such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, 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 22 words ▾

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

📄 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 120 words ▾

PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label AUROHEALTH NDC 58602-618-05 COUGH SUPPRESSANT Dextromethorphan Polistirex Extended-Release Oral Suspension 30 mg/5 mL COUGH 12 HOUR RELIEF CONTAINS NO FEVER REDUCER OR PAIN RELIEVER DAY or NIGHT ALCOHOL FREE Grape Flavored Liquid 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Label

PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label NDC 58602-618-05 Compare to Delsym ® active ingredient * AUROHEALTH COUGH SUPPRESSANT Dextromethorphan Polistirex Extended-Release Oral Suspension 30 mg/5 mL COUGH DAY or NIGHT Alcohol Free 12 HOUR RELIEF Grape Flavored Liquid 89 mL (3 fl oz) PRINCIPAL DISPLAY PANEL - 89 mL (3 fl oz) Bottle Carton Label

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 Polistirex — the ingredient across all brands.

Top reported reactions

Diarrhoea78
Dizziness42
Nausea40
Drug Effect Incomplete34
Hypersensitivity30
Somnolence28
Condition Aggravated26

Reporter sex

0 reports

Serious outcomes

Death11
Life-threatening3
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 145 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 1 other package presentation of this same product, including 1 bottle (58602-0618-06). 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.
← 58602-0617-05 · Aurohealth 58602-0701-01 · 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.