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Nizoral Ketoconazole 10 mg/mL Shampoo — NDC 55505-0196-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nizoral Ketoconazole 10 mg/mL Shampoo — NDC 55505-196-33 (Billing 55505-0196-33)

by Kramer Laboratories · 1 BOTTLE in 1 CARTON / 125 mL in 1 BOTTLE

This is a package of Nizoral Ketoconazole 10 mg/mL Shampoo from Kramer Laboratories, marketed since Jun 2022 and currently FDA-listed. It is the main listing for this product, which comes in 10 package sizes.

NDC 55505-0196-33
🏷️ FDA NDC (as labeled) 55505-196-33 billing pads the product segment with a zero
This package
Contains125 mL in 1 bottle Pack sizes10 compare ↓
Main listing for product 55505-196 · Also comes in: 200 mL 55505-196-40 325 mL 55505-196-64 562 mL 55505-196-85 2 bottles 55505-196-72 2 bottles 55505-196-57 2 bottles 55505-196-84 3 bottles 55505-196-68 4 ml 55505-196-47 400 ml 55505-196-65
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 55505-196-33 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55505 labeler · 196 product · 33 package
Package marketed since
Jun 16, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5550519633 9
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55505-196-33
Product NDC 55505-196
11-digit billing NDC 55505019633
Application # NDA020310
SPL Set ID a17b7424-ee7e-4fcc-b6b3-0904932ae319
Established class (EPC) Azole Antifungal
Mechanism of action Cytochrome P450 3A4 Inhibitors; Cytochrome P450 3A5 Inhibitors; P-Glycoprotein Inhibitors
Chemical class Azoles
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-16
Route TOPICAL
Dosage form SHAMPOO
Substance KETOCONAZOLE
Why two NDCs? The FDA registers this code as 55505-196-33 — 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 → 55505-0196-33. 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.

Clinical

📖 What it is MedlinePlus · NLM

Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used t...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The 2% shampoo treats tinea versicolor, a fungal skin infection that causes light or dark patches. The 2% foam is used for seborrheic dermatitis in people 12 and older. Which one y...
  • Dispense it into the can cap or onto a cool surface, not straight onto your hands, because it melts on warm skin. Pick up small amounts with your fingertips and massage into the ar...
  • The most common are burning or irritation where you apply it. Dryness, redness, itching or a rash can also happen. Call your doctor if the reaction seems like an allergy, including...
  • Yes. It is flammable, so avoid flames, fire and smoking while applying it and right afterward. Do not puncture or burn the can, and keep it away from heat. Keep it out of your eyes...
📖 Read our full Ketoconazole Topical guide →
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: 200 mL 325 mL 562 mL 2 bottles 2 bottles 2 bottles 3 bottles 4 ml 400 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
55505-0196-33 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 125 mL in 1 BOTTLE 2022-06-16 — Active
55505-0196-40 55505-196-40 1 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE 2022-06-16 — Active
55505-0196-64 55505-196-64 1 BOTTLE in 1 CARTON / 325 mL in 1 BOTTLE 2022-06-16 — Discontinued by firm
55505-0196-65 55505-196-65 1 CARTON in 1 CARTON / 400 mL in 1 CARTON 2022-06-16 — Active
55505-0196-72 55505-196-72 2 BOTTLE in 1 CARTON / 325 mL in 1 BOTTLE 2023-12-01 — Active
55505-0196-47 55505-196-47 4 mL in 1 PACKET 2024-03-01 — Active
55505-0196-57 55505-196-57 2 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE 2023-04-29 — Active
55505-0196-68 55505-196-68 3 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE 2022-10-15 — Active
55505-0196-84 55505-196-84 2 BOTTLE in 1 CARTON / 400 mL in 1 BOTTLE 2025-06-01 — Active
55505-0196-85 55505-196-85 1 BOTTLE in 1 CARTON / 562 mL in 1 BOTTLE 2026-01-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 125 ml in 1 bottle.
What NDC number is used to bill for this package of Nizoral Ketoconazole 10 mg/mL Shampoo?
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
Nizoral 10 mg/mLthis 55505-0196-33 Kramer 1 bottle — — FDA listed —
Nizoral 1 g/100mL 55505-0232-65 Kramer 400 ml — — FDA listed —
Nizoral 10 mg/mL 55505-0233-65 Kramer 400 ml — — FDA listed —
Gembooxt Ketoconazole 1% Medicated Shampoos .01 g/mL 76986-0025-01 Guangdong 300 ml — — FDA listed —
1% ketoconazole 10 mg/mL 85384-0001-01 TAGRID 250 ml — — FDA listed —
dandRX 1% Ketoconazole Anti-Dandruff 1 g/100mL 85521-0001-01 dandRX 236 ml — — Discontinued —
Anti Dandruff 1 g/100mL 85593-0033-01 Guangzhou 200 ml — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 1R9DUY89CZ
    A mild cleansing agent derived from coconut oil and amino acids. It works as a surfactant and emulsifier to help mix ingredients together and improve how the product spreads or dissolves on skin or in the mouth.
  • 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 BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • 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.

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

The official label also statesbenzyl alcohol, BHT, blue 1, citric acid, cocamide MEA, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate, tetrasodium EDTA, 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

LabelerKramer Laboratories
Application holderKRAMER LABORATORIES INC
FDA applicationNDA020310 (NDA)
Labeler code55505
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kramer Laboratories labeler code 55505

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Uses controls flaking, scaling and itching associated with dandruff

⏱️ Dosage and Administration 48 words ▾

Directions adults and children 12 years and over wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. Repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff children under 12 years ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 17 words ▾

Other information store at 20°C to 25°C (68°F-77°F) see top panel for lot number and expiration date

🧪 Active Ingredient 8 words ▾

Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo

🧪 Inactive Ingredients 34 words ▾

Inactive ingredients benzyl alcohol, BHT, blue 1, citric acid, cocamide MEA, fragrance, glycol distearate, hydrochloric acid, hydroxypropyl methylcellulose, polyquaternium-7, sodium benzoate, sodium chloride, sodium cocoyl sarcosinate, sodium hydroxide, sodium laureth sulfate, tetrasodium EDTA, water

🎯 Purpose 8 words ▾

Active ingredient Purpose Ketoconazole 1% w/w Anti-dandruff shampoo

📄 Do Not Use 19 words ▾

Do not use on scalp that is broken or inflamed if you are allergic to ingredients in this product

📄 Ask a Doctor Before Use If 18 words ▾

Stop use and ask a doctor if rash appears condition worsens or does not improve in 2-4 weeks

📄 When Using This Product 17 words ▾

When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water

🤰 If Pregnant or Breast-Feeding 9 words ▾

If pregnant or breast-feeding, ask a doctor before use.

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or comments? call 1-800-824-4894

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 7 fl oz (200mL) What Causes Dandruff? Dandruff can have many causes. A fungus found on every human head is often associated with dandruff.

How Does Nizoral ® Anti-Dandruff Work? NIZORAL ® Anti-Dandruff is the only over-the-counter anti-dandruff shampoo that has Ketoconazole, an effective antifungal. Ketoconazole works by controlling fungus often associated with dandruff, and once the fungus is controlled, so are your dandruff symptoms.

Use Nizoral ® Anti-Dandruff just twice a week to control your dandruff symptoms. Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 KRAMER LABORATORIES Made in Canada Distributed by: Kramer Laboratories, Inc.

Bridgewater, NJ 08807 USA © 2022 KRAMER LABORATORIES, INC. Lot: Exp: P819B46100 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO CONTROLS fungus that can cause dandruff Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 7 fl oz (200mL) P819H46000 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 4 fl oz (125mL) P809H45000 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 11 fl oz (325mL) P829H47000 Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 14 fl oz (400 mL) P839H48000 SAMPLE Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 0.4 fl oz (12 mL) Sample Not For Sale Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO VALUE SIZE - TWO 11 OZ BOTTLES Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 2 Bottles: 11 fl oz (325 mL) each Total 22 fl oz (650 mL) Use Nizoral ® Anti-Dandruff just twice a week to control your dandruff symptoms.

What Causes Dandruff? Dandruff can have many causes. A fungus found on every human head is often associated with dandruff.

How Does Nizoral ® Anti-Dandruff Work? NIZORAL ® Anti-Dandruff is the only over-the-counter anti-dandruff shampoo that has Ketoconazole, an effective antifungal. Ketoconazole works by controlling fungus often associated with dandruff, and once the fungus is controlled, so are your dandruff symptoms.

Anti-Dandruff Shampoo Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 KRAMER LABORATORIES Made in Canada Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2023 KRAMER LABORATORIES, INC.

Nizoral ® Anti-Dandruff KETOCONAZOLE 1% ANTI-DANDRUFF SHAMPOO Anti-Dandruff Shampoo CLINICALLY PROVEN to control flaking, scaling and itching from dandruff CONTROLS fungus that can cause dandruff CLEAN fresh scent 19 fl oz (562mL) What Causes Dandruff? Dandruff can have many causes. A fungus found on every human head is often associated with dandruff.

How Does Nizoral ® Anti-Dandruff Work? NIZORAL ® Anti-Dandruff is the only over-the-counter anti-dandruff shampoo that has Ketoconazole, an effective antifungal. Ketoconazole works b… [Excerpted — this section continues on DailyMed.]

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 Ketoconazole (matched by generic name) — the program that covers self-administered drugs. 13 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 Ketoconazole. CMS lists 2 products for this generic; we show the highest-spend one. 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
$20.47M
Claims incl. refills
1.2M
Beneficiaries
831.7K
Spend / beneficiary
$24.61
Spend / claim
$17.69
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 Kramer Laboratories. 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 9 other package presentations of this same product, including 1 bottle (55505-0196-40), 1 bottle (55505-0196-64), 1 bottle (55505-0196-85). 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?
Kramer Laboratories 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.
← 55505-0195-62 · Kramer 55505-0197-07 · Kramer →
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.