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Cetirizine Hydrochloride (Allergy) 10 mg Capsule, 65-count — NDC 58602-0716-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cetirizine Hydrochloride (Allergy) 10 mg Capsule, 65-count — NDC 58602-716-16 (Billing 58602-0716-16)

by Aurohealth LLC · 1 BOTTLE in 1 CARTON / 65 CAPSULE in 1 BOTTLE

This is a package of 65 capsules of Cetirizine Hydrochloride (Allergy) 10 mg Capsule from Aurohealth LLC, marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 58602-0716-16
🏷️ FDA NDC (as labeled) 58602-716-16 billing pads the product segment with a zero
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

⚠️
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Jun 24, 2026 — Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0732-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0032-2026
Class III · Sep 12, 2025 — Tablet/Capsules Imprinted with Wrong ID (JB Chemicals and Pharmaceuticals Ltd) · FDA recall D-0033-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-716-16
Product NDC 58602-716
11-digit billing NDC 58602071616
RxCUI 1014675
UNII 64O047KTOA
Application # ANDA209107
SPL Set ID 1bbefda2-d3c5-4d31-b3ec-7da077e41157
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-16
Route ORAL
Dosage form CAPSULE
Substance CETIRIZINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1014675
Why two NDCs? The FDA registers this code as 58602-716-16 — 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 → 58602-0716-16. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives, Other antiallergics
How it works Histamine H1 Receptor Antagonists
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 it is MedlinePlus · NLM

Cetirizine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Cetirizine is also used to treat urticaria (hives; itchy raised red bumps on skin). Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine. This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves allergy symptoms. Over-the-counter versions ease runny nose, sneezing, itchy, watery eyes and an itchy nose or throat from hay fever. Specific products treat hives, yea...
  • It can. Drowsiness was reported, and it was more common at higher doses in children. Be careful driving or using machinery until you know how it affects you, and avoid alcohol.
  • The oral solution can be taken with or without food. Food slightly delays how fast it works but does not change how much your body absorbs.
  • Check with me first if you take sedatives or tranquilizers, since they can add to drowsiness. The label found no significant interactions with azithromycin, pseudoephedrine, ketoco...
📖 Read our full Cetirizine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:

BeerModerate WineModerate Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Cetirizine Hydrochloride (5 interactions) — ranked by severity →
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.
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
58602-0716-16 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 65 CAPSULE in 1 BOTTLE 2022-08-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetirizine HCl 10 mg 46122-0613-63 AMERISOURCE 25 capsules $0.196 — Availability likely —
Good Sense All Day Allergy 10 mg 00113-0981-63 L. 25 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 00363-0068-12 WALGREEN 40 capsules — — FDA listed —
24 Hour Allergy 10 mg 00363-1219-15 Walgreens 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 00363-6341-15 WALGREEN 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 11673-0242-15 TARGET 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 11673-0650-15 TARGET 40 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 11822-4228-01 RITE 25 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 21130-0099-97 Better 25 capsules — — FDA listed —
Allergy Relief 10 mg 21130-0364-25 Safeway, 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 30142-0995-25 KROGER 25 capsules — — FDA listed —
top care all day allergy 10 mg 36800-0180-09 Topco 65 capsules — — FDA listed —
topcare all day allergy 10 mg 36800-0448-09 Topco 65 capsules — — FDA listed —
Cetirizine HCl 10 mg 36800-0542-15 TOP 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 36800-0543-15 TOP 40 capsules — — FDA listed —
Allergy Relief 10 mg 37808-0564-25 H 25 capsules — — FDA listed —
all day allergy 10 mg 41163-0219-08 SUPERVALU 12 capsules — — FDA listed —
24 hour allergy 10 mg 41250-0618-63 Meijer 25 capsules — — FDA listed —
All Day Allergy 10 mg 41520-0212-25 Care 25 capsules — — FDA listed —
CareOne Allergy Relief 10 mg 41520-0715-63 American 25 capsules — — FDA listed —
Allergy Relief 10 mg 42681-0056-01 Whole 30 capsules — — FDA listed —
Cetirizine HCl 10 mg 46122-0815-64 AMERISOURCE 25 capsules — — FDA listed —
Allergy Relief 10 mg 49035-0841-25 EQUATE 25 capsules — — FDA listed —
ZYRTEC Allergy 10 mg 50580-0786-12 Kenvue 12 capsules — — FDA listed —
Allergy Relief 10 mg 51316-0064-25 CVS 25 capsules — — FDA listed —
Allergy Relief 10 mg 51316-0810-05 CVS 40 capsules — — FDA listed —
Allergy Relief 10 mg 51316-0811-25 CVS 25 capsules — — FDA listed —
Allergy Relief 10 mg 53943-0219-40 DISCOUNT 40 capsules — — FDA listed —
dg health all day allergy 10 mg 55910-0710-49 Dolgencorp, 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 55910-0784-15 DOLGENCORP 40 capsules — — FDA listed —
dg health all day allergy 10 mg 55910-0934-49 Dolgencorp 40 capsules — — FDA listed —
Allergy Relief 10 mg 56062-0064-25 Publix 25 capsules — — Discontinued —
allergy relief 10 mg 56062-0111-63 Publix 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 56062-0452-86 PUBLIX 25 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mgthis 58602-0716-16 Aurohealth 65 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0806-04 Aurohealth 12 capsules — — FDA listed —
Cetirizine Hydrochloride (Hives Relief) 10 mg 58602-0808-04 Aurohealth 12 capsules — — FDA listed —
Cetirizine Hydrochloride (Allergy) 10 mg 58602-0863-12 Aurohealth 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 59450-0020-15 KROGER 40 capsules — — FDA listed —
All Day Allergy Relief 10 mg 59726-0064-12 P 12 capsules — — FDA listed —
All Day Allergy Relief 10 mg 59726-0741-12 P 12 capsules — — FDA listed —
All Day Allergy Relief 10 mg 63868-0433-25 CHAIN 25 capsules — — FDA listed —
Allergy Relief 10 mg 69168-0392-25 Allegiant 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 69452-0265-15 Bionpharma 40 capsules — — FDA listed —
Cetirizine HCl 10 mg 69452-0479-88 Bionpharma 65 capsules — — FDA listed —
basic care all day allergy 10 mg 72288-0007-49 Amazon.com 40 capsules — — FDA listed —
basic care all day allergy 10 mg 72288-0980-49 Amazon.com 40 capsules — — FDA listed —
Allergy Relief 10 mg 72476-0064-25 Care 25 capsules — — FDA listed —
careone allergy relief 10 mg 72476-0623-63 Retail 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 79481-0670-02 Meijer 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 79481-0671-02 Meijer 25 capsules — — FDA listed —
24 hour allergy 10 mg 79481-0981-00 Meijer, 25 capsules — — Discontinued —
All Day Allergy 10 mg 79903-0084-25 WALMART 25 capsules — — FDA listed —
Allergy Relief 10 mg 79903-0344-25 WALMART 25 capsules — — FDA listed —
Allergy Relief 10 mg 79903-0347-25 WALMART 25 capsules — — FDA listed —
Cetirizine HCl 10 mg 80136-0856-23 Northeast 25 capsules — — FDA listed —
Zyrtec Allergy Cetirizine HCl 10 mg 67414-0012-00 Jones 90 capsules — — FDA listed —
cetirizine hydrochloride 10 mg 59556-0894-12 Strides 40 capsules — — FDA listed —
Amazon Basics All Day Allergy Relief 10 mg 72288-0013-40 Amazon.com 40 capsules — — FDA listed —
Zyrtec Allergy Cetirizine HCl 10 mg 67414-0013-01 Jones 12 capsules — — 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
Aug 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 Yellow
ShapeOval
ImprintCZ10
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 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.

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

The official label also statesgelatin, glycerin, polyethylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

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 applicationANDA209107 (ANDA)
Labeler code58602
First marketedAug 2022
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 63 words ▾

Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 26 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

📦 Storage and Handling 37 words ▾

Other information store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each capsule) Cetirizine HCI USP 10 mg

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Ask a Doctor Before Use If 22 words ▾

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

📄 When Using This Product 27 words ▾

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 If Pregnant or Breast-Feeding 16 words ▾

If pregnant or breast-feeding: If breast-feeding: not recommended if pregnant: 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 right away. (1-800-222-1222)

📄 Questions or Comments 30 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 Code: TS/DRUGS/16/2014

📄 Package Label / Principal Display Panel 118 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (65's Capsule Container Label) Healthy Living TM Allergy Original Prescription Strength CETIRIZINE HCl Capsules 10 mg Antihistamine Indoor + Outdoor Allergies READ AND KEEP THE OUTER PACKAGE FOR 65 LIQUID GELS * COMPLETE WORNINGS AND INFORMATION *liquid-filled capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label) Healthy Living TM Allergy Original Prescription Strength CETIRIZINE HCl Capsules 10 mg Antihistamine Indoor + Outdoor Allergies *Compare to the Active Ingredient in CZ10 Zyrtec® (Actual Size) 24 Hour Relief of: • Sneezing • Runny Nose 65 Liquid Gels* • Itchy, Watery Eyes • Itchy Throat or Nose *liquid-filled capsules figure

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

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.
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.
← 58602-0715-05 · Aurohealth 58602-0717-30 · 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.