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DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment MINOXIDIL 50 mg/mL Solution — NDC 69188-0593-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment MINOXIDIL 50 mg/mL Solution — NDC 69188-593-03 (Billing 69188-0593-03)

by DS Healthcare Group · 3 BOTTLE, SPRAY in 1 BOX / 60 mL in 1 BOTTLE, SPRAY

This is a package of DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment MINOXIDIL 50 mg/mL Solution from DS Healthcare Group, marketed since Feb 2025 and currently FDA-listed.

NDC 69188-0593-03
🏷️ FDA NDC (as labeled) 69188-593-03 billing pads the product segment with a zero
This package
Contains60 mL in 1 bottle, spray Pack sizes2 compare ↓
Product page 69188-0593-00 Also comes in: 60 mL 69188-593-00
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 69188-593-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69188 labeler · 593 product · 03 package
Package marketed since
Feb 26, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0816378021727, 0816378021888
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69188-593-03
Product NDC 69188-593
11-digit billing NDC 69188059303
RxCUI 1537948
UNII 5965120SH1
UPC 0816378021727, 0816378021888
Application # ANDA076239
SPL Set ID f11e1944-dea6-469f-9ef4-ccce47a7e0fe
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-26
Route TOPICAL
Dosage form SOLUTION
Substance MINOXIDIL
Quick answers
  • RxCUI (RxNorm): 1537948
Why two NDCs? The FDA registers this code as 69188-593-03 — 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 → 69188-0593-03. 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 Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Pyrimidine derivatives, Other dermatologicals
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

Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can flow more easily through the body. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The topical products in the label are specifically approved for hair regrowth on the top of the scalp only — not for use on other parts of the body. Applying it elsewhere isn't rec...
  • Can I use the topical minoxidil solution on my beard or other areas, not just my scalp?
  • Hair regrowth takes time and patience. Some people start to see results after about 2 months of twice-daily use, but for others it may take 4 months or more. Not everyone responds...
  • How long does it take to see results with topical minoxidil?
📖 Read our full Minoxidil guide →
1
Nutrient depletion considerations

Minoxidil may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Minoxidil nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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: 60 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
69188-0593-00 69188-593-00 Main listing 1 BOTTLE, SPRAY in 1 BOX / 60 mL in 1 BOTTLE, SPRAY 2025-02-26 — Active
69188-0593-03 You're viewing this 3 BOTTLE, SPRAY in 1 BOX / 60 mL in 1 BOTTLE, SPRAY 2025-02-26 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 bottle, spray in 1 box / 60 ml in 1 bottle, spray.
What NDC number is used to bill for this package of DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment MINOXIDIL 50 mg/mL Solution?
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
BOSLEY Minoxidil Topical Solution 5 (for men) 50 mg/mL 69113-0483-00 Scientific 1 bottle — — FDA listed —
DS Labs Spectral UHP Men s Extra Strength Hair Regrowth Treatment 50 mg/mLthis 69188-0593-03 DS 3 bottles — — FDA listed —
Minoxidil Extra Strength for Men 5 g/100mL 72484-0097-01 Roman 3 bottles — — FDA listed —
Elevate Hair Regrowth Treatment 5 50 mg/mL 84561-0524-00 VAPOR 1 bottle — — FDA listed —
5% Minoxidil HAIR GROWTH SPARY 5 g/100mL 84778-0099-01 Guangzhou 1 bottle — — Discontinued —
5%Minoxidilhairgrowthspray 5 g/100mL 84778-0105-01 Guangzhou 1 bottle — — Discontinued —
Minoxidil hair growth serum 50 mg/100mL 84867-0005-01 Jiashen 100 ml — — FDA listed —
Minoxidil Hair Growth Serum 5 g/100mL 85092-0001-01 Shenzhen 1 bottle — — Discontinued —
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth Solution 5 g/100mL 85636-0010-01 Shenzhen 60 ml — — FDA listed —
iBeaLee 5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0018-01 Shenzhen 60 ml — — FDA listed —
5% Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0023-01 Shenzhen 60 ml — — FDA listed —
Minoxidil Hair Regrowth Treatment 5 g/100mL 85636-0024-01 Shenzhen 60 ml — — FDA listed —
Gainxtra Hair Regrowth Treatment for Men and Women Minoxidil 5% Sprays with Biotin 50 mg/mL 85929-0100-01 GAINXTRA 1 bottle — — Discontinued —
DAAZZS 5% Minoxidil Hair and Beard Regrowth Kit with Biotin 5 g/100mL 87408-0008-01 Guangzhou 2 bottles — — FDA listed —
FUZYAT 5% Minoxidil Hair Growth for Men and Women 5 g/100mL 87408-0015-01 Guangzhou 2 bottles — — FDA listed —
Hair Growth Serum 5 g/100mL 87540-0001-01 Shenzhen 60 ml — — FDA listed —
Regenpure Precision 50 mg/mL 71290-0813-02 Salonceuticals, 1 bottle — — FDA listed —
Minoxidil 50 mg/mL 00363-9971-02 Walgreens 1 bottle — — Discontinued —
BOSLEY Man 5 Minoxidil Topical Solution 50 mg/mL 69113-0431-00 Scientific 1 bottle — — FDA listed —
SUAVECITO 5% Minoxidil Solution 50 mg/mL 74866-0414-01 SUAVECITO, 1 bottle — — FDA listed —
INTELLIGENT Mens Minoxidil Extra Strength 5 Minoxidil 50 mg/mL 81632-0408-00 INTELLIGENT 1 bottle — — FDA listed —
Elevate Hair Regrowth Treatment 5 Minoxidil Solution 50 mg/mL 84561-0514-00 VAPOR 1 bottle — — FDA listed —
RegrowthX Hair Regrowth Treatment Minoxidil 50 mg/mL 87148-0881-00 Nimex 1 bottle — — FDA listed —
Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment 50 mg/mL 69607-9540-00 WR 3 bottles — — FDA listed —
Minoxidil 50 mg/mL 00363-9973-06 Walgreens 3 bottles — — FDA listed —
Hair Regrowth Treatment Extra Strength for Men 50 mg/mL 82269-0607-02 Seiseidou 1 bottle — — Discontinued —
Nuvarra Mens Minoxidil Hair Regrowth Treatment 50 mg/mL 87779-0966-00 Bionetics 1 bottle — — FDA listed —
Mens Rogaine Extra Strength Unscented 50 mg/mL 69968-0089-01 Kenvue 1 bottle — — FDA listed —
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength 50 mg/mL 84180-0878-00 NUEPHASE 1 bottle — — FDA listed —
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength 50 mg/mL 84856-0603-00 ESALON.COM, 1 bottle — — FDA listed —
Mens Extra Strength Minoxidil Hair Growth Treatment 50 mg/mL 87616-0969-00 Hairmax 1 bottle — — FDA listed —
DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment 50 mg/mL 82372-0482-00 Good 1 bottle — — FDA listed —
Stafenit Hair Regrowth Treatment Topical Minoxidil 50 mg/mL 85097-0576-00 Cozesmo 1 bottle — — FDA listed —
ProBliva Mens Extra Strength Minoxidil 50 mg/mL 85464-0595-00 CAVTECH 1 bottle — — FDA listed —
RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil 50 mg/mL 87663-0962-00 TrueRoot 1 bottle — — FDA listed —
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil 50 mg/mL 84329-0465-00 APIRA 1 bottle — — FDA listed —
Mens Jivexa Extra Strength Minoxidil 50 mg/mL 87688-0955-00 SMC 1 bottle — — FDA listed —
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented 50 mg/mL 81352-0560-00 SANTO 1 bottle — — FDA listed —
Tomum Hair Growth Treatment For Men Minoxidil Unscented 50 mg/mL 85003-0546-00 BELLEKA 1 bottle — — FDA listed —
Happy Head Mens Extra Strength Minoxidil 50 mg/mL 87117-0882-00 Happy 3 bottles — — FDA listed —
OpusMeds Extra Strength Minoxidil 50 mg/mL 87338-0983-00 Opus 1 bottle — — FDA listed —
Dr. Bosley Minoxidil (For Men) Hair Regrowth Treatment 50 mg/mL 69113-0913-00 Scientific 1 bottle — — FDA listed —
Follicly Minoxidil Hair Regrowth Treatment 50 mg/mL 87884-0006-00 Follicly 1 bottle — — FDA listed —
Olivita Extra Strength Minoxidil 50 mg/mL 87695-0008-00 Olivita 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

🧪 Avoiding an ingredient? See Minoxidil inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesalcohol, propylene glycol, purified water

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

LabelerDS Healthcare Group
Application holderPURE SOURCE LLC
FDA applicationANDA076239 (ANDA)
Labeler code69188
First marketedFeb 2025
Product typeHuman Otc Drug

More NDCs from DS Healthcare Group labeler code 69188

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 📄 Ask a Doctor 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 18 words ▾

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

⏱️ Dosage and Administration 71 words ▾

Directions prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist. apply 1 mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

⚠️ Warnings ~1 min read ▾

Warnings For external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp.

Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. you have no family history of hair loss hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. it takes time to regrow hair.

Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men. some people have experienced changes in hair color and/or texture Stop use and ask a doctor if chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 11 words ▾

Active ingredient Minoxidil 5% w/v Purpose Hair regrowth treatment for men

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients alcohol, propylene glycol, purified water

🎯 Purpose 6 words ▾

Purpose Hair regrowth treatment for men

📄 Do Not Use 101 words ▾

Do not use if you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. you have no family history of hair loss hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp

📄 Ask a Doctor Before Use If 10 words ▾

Ask a doctor before use if you have heart disease

📄 When Using This Product 96 words ▾

When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. it takes time to regrow hair. Results may occur at 2 months with twice a day usage.

For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. This product will not work for all men. some people have experienced changes in hair color and/or texture

📄 Stop Use and Ask a Doctor If 45 words ▾

Stop use and ask a doctor if chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months

🤰 If Pregnant or Breast-Feeding 9 words ▾

May be harmful if used when pregnant or breast-feeding.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 13 words ▾

Questions or comments? call toll free (888) 829-4212 or visit website at www.dslaboratories.com

📄 Package Label / Principal Display Panel 16 words ▾

Package Labeling: Label Carton Label Bottle Box Box2

Package Labeling: Label Carton2 Label Bottle2 Box3 Box4

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Minoxidil (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Minoxidil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.5M
Claims incl. refills
260.9K
Beneficiaries
202.1K
Spend / beneficiary
$17.33
Spend / claim
$13.42
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 DS Healthcare Group. 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 (69188-0593-00). 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?
DS Healthcare Group 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.
← 69188-0300-07 · DS 69197-0029-20 · Command →
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.