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Docosanol 100 mg/g Cream — NDC 58602-0019-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Docosanol 100 mg/g Cream — NDC 58602-019-08 (Billing 58602-0019-08) · Product 58602-019

by Aurohealth LLC · 1 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE

NDC 58602-019-08 (billing 58602-0019-08) is a package of Docosanol 100 mg/g Cream from Aurohealth LLC, marketed since Mar 2024 and currently FDA-listed. It is the main listing for product NDC 58602-019, which comes in 9 package sizes.

NDC 58602-0019-08
🏷️ FDA NDC (as labeled) 58602-019-08 billing pads the product segment with a zero
This package
Contains2 g in 1 tube Pack sizes9 compare ↓
Main listing for product 58602-019 · Also comes in: 3 g 58602-019-11 3 g 58602-019-12 2 g 58602-019-15 2 g 58602-019-16 2 g 58602-019-24 2 tubes 58602-019-09 2 tubes 58602-019-13 2 bottles 58602-019-17
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) 58602-019-08
Product NDC 58602-019
11-digit billing NDC 58602001908
RxCUI 797534
UNII 9G1OE216XY
Application # ANDA217090
SPL Set ID 9f361f24-a0a1-4e43-a158-8c830c9adca7
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-01
Route TOPICAL
Dosage form CREAM
Substance DOCOSANOL
Quick answers for NDC 58602-019-08
  • RxCUI (RxNorm): 797534
  • 11-digit billing NDC: 58602001908
Why two NDCs? The FDA registers this code as 58602-019-08 — 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 → 58602-0019-08. 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 Antivirals class.

Drug family (ATC) Antivirals
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 treats cold sores, also called fever blisters, on your face or lips. It can shorten healing time and how long tingling, pain, burning and itching last.
  • Start at the very first sign, usually a tingle. Early treatment gives the best results. Wash your hands before and after, then rub it in gently but completely.
  • Adults and children 12 and older use it 5 times a day until the cold sore heals. If your child is under 12, check with a doctor first.
  • It can rarely cause a severe allergic reaction, with hives, facial swelling, wheezing, rash or trouble breathing. If that happens, stop and get medical help right away. Do not use...
📖 Read our full Docosanol guide →

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Docosanol (3 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 gPer 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: 3 g 3 g 2 g 2 g 2 g 2 tubes 2 tubes 2 bottles
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
58602-0019-08 58602-019-08 You're viewing this Main listing 1 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE 2024-03-01 — Active
58602-0019-09 58602-019-09 2 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE 2024-03-01 — Active
58602-0019-11 58602-019-11 1 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE 2024-03-01 — Active
58602-0019-12 58602-019-12 1 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE 2024-03-01 — Active
58602-0019-13 58602-019-13 2 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE 2024-03-01 — Active
58602-0019-15 58602-019-15 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP 2024-03-01 — Active
58602-0019-16 58602-019-16 1 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP 2024-03-01 — Active
58602-0019-17 58602-019-17 2 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP 2024-03-01 — Active
58602-0019-24 58602-019-24 1 TUBE in 1 PACKAGE (58602-019-24) / 2 g in 1 TUBE 2024-03-01 — Active

Pack size FAQ

What quantity is in NDC 58602-0019-08?
NDC 58602-0019-08 is listed by the FDA — 1 tube in 1 package / 2 g in 1 tube.
What NDC number is used to bill for this package of Docosanol 100 mg/g Cream?
Bill NDC 58602-0019-08 — the 11-digit billing format is 58602001908. 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
Docosanol 100 mg/g 00536-1427-04 Rugby 1 tube $5.793 — Availability likely —
Docosanol 100 mg/g 00713-0353-02 Cosette 1 tube $5.793 — Availability likely —
Docosanol 100 mg/g 46122-0800-36 Amerisource 1 tube $5.793 — Availability likely —
Docosanol 100 mg/g 51672-1406-02 Sun 2 tubes $5.793 — Availability likely —
Docosanol 100 mg/g 61269-0881-35 H2-Pharma, 2 g $5.793 — Availability likely —
Docosanol 100 mg/g 61269-0989-37 H2-Pharma, 1 bottle $5.793 — Availability likely —
Docosanol 100 mg/g 70000-0672-01 Leader/ 1 tube $5.793 — Availability likely —
Cold Sore Fever Blister Treatment 100 mg/g 70677-1255-01 Strategic 1 tube $5.793 — Availability likely —
Docosanol 100 mg/g 62011-0433-01 Strategic 1 tube $5.946 — FDA listed —
Abreva 100 mg/g 00135-0200-01 Haleon 2 g — — FDA listed —
Abreva 100 mg/g 00135-0300-01 Haleon 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-6510-07 Walgreens 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-8877-07 Walgreens 2 g — — FDA listed —
Docosanol 100 mg/g 00363-8980-07 Walgreens 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-9220-07 Walgreens 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 00363-9222-07 Walgreens 1 tube — — FDA listed —
Cold Sore Treatment Docosanol 100 mg/g 10157-2124-02 Blistex 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 11673-0769-14 TARGET 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 11673-0846-14 TARGET 2 tubes — — FDA listed —
Docosanol 100 mg/g 21130-0422-07 Safeway, 1 tube — — Discontinued —
Cold Sore Fever Blister Treatment 100 mg/g 21130-0605-07 Safeway, 2 g — — FDA listed —
Docosanol 100 mg/g 21130-0770-07 Safeway, 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 21130-0823-07 Safeway, 1 tube — — FDA listed —
Docosanol 100 mg/g 21922-0023-17 Encube 1 bottle — — FDA listed —
Docosanol 100 mg/g 30142-0286-02 KROGER 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 30142-0322-07 The 1 tube — — Discontinued —
Cold Sore Fever Blister Treatment 100 mg/g 30142-0869-07 The 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 30142-0981-07 The 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 37808-0223-07 H 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 37808-0229-07 H 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 37808-0661-07 H 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 37808-0765-07 H 2 g — — FDA listed —
Docosanol 100 mg/g 41163-0724-07 United 1 tube — — FDA listed —
Docosanol 100 mg/g 41250-0867-07 MEIJER, 1 tube — — FDA listed —
Docosanol 100 mg/g 41415-0660-03 Publix 1 tube — — FDA listed —
Docosanol 100 mg/g 46708-0682-01 Alembic 1 tube — — FDA listed —
Docosanol 100 mg/g 49035-0259-35 EQUATE 1 tube — — FDA listed —
Docosanol 100 mg/g 51316-0763-02 CVS 1 tube — — FDA listed —
Docosanol 100 mg/g 55301-0112-07 AAFES/Your 1 tube — — FDA listed —
Docosanol 100 mg/g 55301-0877-07 AAFES/Your 1 tube — — FDA listed —
Docosanol 100 mg/g 55319-0922-07 Family 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0550-07 Dolgencorp, 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0859-07 Dolgencorp, 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 55910-0963-07 Dolgencorp, 1 tube — — FDA listed —
Docosanol 100 mg/gthis 58602-0019-08 Aurohealth 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0112-07 P 1 tube — — FDA listed —
Cold Sore Fever Blister 100 mg/g 59726-0221-07 P 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 59726-0877-07 P 2 g — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0922-07 P 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 59726-0924-07 P 1 tube — — FDA listed —
Docosanol 100 mg/g 62332-0682-01 Alembic 1 tube — — FDA listed —
Docosanol 100 mg/g 63941-0922-07 Best 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 68016-0344-07 Chain 1 tube — — FDA listed —
Docosanol 100 mg/g 70000-0743-01 Leader/ 1 bottle — — FDA listed —
Amazon Basics Docosanol 100 mg/g 72288-0006-01 Amazon.com 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0492-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0922-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 72476-0965-07 Care 1 tube — — FDA listed —
Docosanol 100 mg/g 73581-0004-02 YYBA 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 76162-0818-07 Topco 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 76162-0900-07 Topco 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79481-0065-07 Meijer 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79481-9220-07 Meijer 2 tubes — — FDA listed —
Docosanol 100 mg/g 79903-0011-07 WALMART 1 tube — — FDA listed —
Docosanol 100 mg/g 79903-0118-14 WALMART 2 tubes — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79903-0248-07 WALMART 1 tube — — FDA listed —
Docosanol 100 mg/g 79903-0402-10 WALMART 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 79903-0435-00 WALMART 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 81522-0112-07 FSA 1 tube — — FDA listed —
Cold Sore Treatment 100 mg/g 81522-0922-07 FSA 1 tube — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 81522-0923-07 FSA 1 tube — — FDA listed —
Julie Cold Sore Treatment 100 mg/g 82791-0362-01 Julie 2 g — — FDA listed —
Cold Sore Fever Blister Treatment 100 mg/g 85766-0239-02 Sportpharm 1 tube — — FDA listed —
Docosanol 100 mg/g 84725-0001-01 KLM 1 tube — — FDA listed —
Docosanol 100 mg/g 43598-0044-02 Dr.Reddys' 1 tube — — 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

🏛️
2024
On the market since
Mar 2024
📍
2026
Currently FDA-listed
2 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
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.

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 applicationANDA217090 (ANDA)
Labeler code58602
First marketedMar 2024
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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

⏱️ Dosage and Administration 70 words ▾

Directions adults and children 12 years or over: wash hands before and after applying cream apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle) early treatment ensures the best results rub in gently but completely use 5 times a day until healed children under 12 years: ask a doctor Other information store at 20° to 25°C (68° to 77°F) do not freeze

⚠️ Warnings 43 words ▾

Warnings Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: • hives • facial swelling • wheezing/difficulty breathing • shock • rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only

🧪 Active Ingredient 6 words ▾

Drug Facts Active ingredient Docosanol 10%

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate Questions or comments? call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

🎯 Purpose 5 words ▾

Purpose Cold sore/fever blister treatment

📄 Do Not Use 14 words ▾

Do not use • if you are allergic to any ingredient in this product

📄 When Using This Product 38 words ▾

When using this product • apply only to affected areas • do not use in or near the eyes • avoid applying directly inside your mouth • do not share this product with anyone. This may spread infection.

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if • your cold sore gets worse or the cold sore is not healed within 10 days

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube) Docosanol Cream 10% Cold Sore/Fever Blister Treatment For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Label 10% (2 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube) AUROHEALTH # Compare to the active ingredient in Abreva ® NDC 58602-019-08 Docosanol Cream 10% Cold Sore/Fever Blister Treatment Shortens Healing Time and Duration of Symptoms • Tingling • Pain • Burning • Itching The only FDA Approved Medicine to SHORTEN HEALING TIME* For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Square Blister Card Label 10% (2 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube) AUROHEALTH NDC 58602-019-24 # Compare to the active Ingredient in Abreva ® Docosanol Cream 10% Cold Sore/Fever Blister Treatment Shortens Healing Time and Duration of Symptoms • Tingling • Pain • Burning • Itching The only FDA Approved Medicine to SHORTEN HEALING TIME* For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Tube Clamshell Blister Card label 10% (2 g Tube)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Label 10% (2 g Pump) AUROHEALTH NDC 58602-019-14 Docosanol Cream 10% Cold Sore/ Fever Blister Treatment For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Label 10% (2 g Pump)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Square Blister Card Label 10% (2 g Pump) AUROHEALTH # Compare to the active ingredient in Abreva ® NDC 58602-019-15 Docosanol Cream 10% Cold Sore/Fever Blister Treatment Shortens Healing Time and Duration of Symptoms • Tingling • Pain • Burning • Itching Convenient PORTABLE Pump The only FDA Approved Medicine to SHORTEN HEALING TIME* For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Square Blister Card Label 10% (2 g Pump)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Clamshell Blister Card Label 10% (2 g Pump) AUROHEALTH # Compare to the active Ingredient in Abreva ® NDC 58602-019-16 Docosanol Cream 10% Cold Sore/Fever Blister Treatment Shortens Healing Time and Duration of Symptoms • Tingling • Pain • Burning• Itching Convenient PORTABLE Pump The only FDA Approved Medicine to SHORTEN HEALING TIME* For Topical Use Only NET WT 2 g (0.07 oz) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Pump Clamshell Blister Card Label 10% (2 g Pump)

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) — 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 FDA registers it as 58602-019-08, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58602-0019-08, written without dashes as 58602001908. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58602-0019-08, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0019) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
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 8 other package presentations of this same product, including 1 tube (58602-0019-11), 1 tube (58602-0019-12), 1 bottle (58602-0019-15). 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.
← 58602-0018-04 · Aurohealth 58602-0020-07 · 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.