Home › NDC Lookup › Ingredients › Malathion › 51672-5293-04
Ovide Malathion .0005 g/mL Lotion — NDC 51672-5293-04 package photo

Ovide Malathion .0005 g/mL Lotion

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE in 1 CARTON (51672-5293-4) / 59 mL in 1 BOTTLE
NDC 51672-5293-04
🏷️ FDA NDC (as labeled) 51672-5293-4 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 51672-5293-4
Product NDC 51672-5293
11-digit billing NDC 51672529304
NCPDP billing unit ML — per mL (volume)
UNII U5N7SU872W
Application # ANDA091559
SPL Set ID 945f46fa-4b79-49fd-a890-477f251e2164
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-01-31
Route TOPICAL
Dosage form LOTION
Substance MALATHION
GCN Seq No 007657
GCN 31600
HICL code 003338
Ingredient (HICL) Malathion
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5R
Therapeutic class — specific (HIC3) Topical Antiparasitics
AHFS code 84:04.12.00
AHFS class Scabicides And Pediculicides
FDB label name OVIDE 0.5% LOTION
FDB brand name Ovide
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 51672-5293-4 — a 5-4-1 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 package segment → 51672-5293-04. 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.

🏭 Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUVEN PHARMACEUTICALS LTD
FDA applicationANDA091559 (ANDA)
Labeler code51672
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio889 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.

🩺 Clinical

Label name OVIDE 0.5% LOTION Ingredient Malathion
📖 What it is MedlinePlus · NLM

Malathion lotion is used to treat head lice (small insects that attach themselves to the skin) in adults and children 6 years of age and older. It should not be used in infants and children younger than 2 years of age. Malathion is in a class of medications called pediculicides. It works by killing lice.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 9MC3I34447
    A natural oil extracted from citrus peel, used as a flavoring agent and solvent to improve taste and help dissolve or distribute other ingredients in the medicine.
  • UNII 5EXL5H740Y
    A natural oil extracted from Scotch pine needles, used as a flavoring agent and fragrance component in medicines. It adds taste and aroma to improve how the medication tastes or smells.
  • UNII R53Q4ZWC99
    Terpineol is a fragrant alcohol derived from pine oil or other plant sources. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.

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

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.

💲 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 · Q2 2026 $4.28 —
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Malathion .0005 g/mL 51672-5294-04 Sun 1 bottle $3.201 — Availability likely —
Ovide .0005 g/mLthis 51672-5293-04 Sun 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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.

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

Medicare Part D (outpatient prescription) spending for Malathion (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Malathion. 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
$60.2K
Claims incl. refills
274
Beneficiaries
206
Spend / beneficiary
$292.46
Spend / claim
$219.88
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51672-5293-04 You're viewing this 1 BOTTLE in 1 CARTON (51672-5293-4) / 59 mL in 1 BOTTLE 2014-01-31 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 FDA registers it as 51672-5293-4, 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: 51672-5293-04, written without dashes as 51672529304. 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 51672-5293-04, the first segment (51672) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (5293) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

⏱️ Dosage and Administration 125 words ▾

DOSAGE AND ADMINISTRATION Apply OVIDE Lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying OVIDE Lotion. Wash hands after applying to scalp.

Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered. After 8 to 12 hours, the hair should be shampooed. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs.

If lice are still present after 7 - 9 days, repeat with a second application of OVIDE Lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

⛔ Contraindications 45 words ▾

CONTRAINDICATIONS OVIDE Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. OVIDE Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.

⚠️ Warnings ~3 min read ▾

WARNINGS OVIDE Lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet.

Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. OVIDE Lotion should only be used on children under the direct supervision of an adult. If OVIDE Lotion comes into contact with the eyes, flush immediately with water.

Consult a physician if eye irritation persists. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the OVIDE Lotion, and if irritation reoccurs, consult a physician.

Chemical burns including second-degree burns and stinging sensations may occur with the use of OVIDE Lotion. General Keep out of reach of children. Close eyes tightly during product application.

If accidentally placed in the eye, flush immediately with water. Use only on scalp hair. Information to Patients OVIDE Lotion is flammable.

The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. The person applying OVIDE Lotion should wash hands after application.

Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. OVIDE Lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet.

In case of accidental ingestion of OVIDE Lotion by mouth, seek medical attention immediately. If you are pregnant or nursing, you should contact your physician before using OVIDE Lotion. If OVIDE Lotion comes into contact with the eyes, flush immediately with water.

Consult a physician if eye irritation persists or if visual changes occur. If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, OVIDE Lotion may be reapplied.

If irritation reoccurs, consult a physician. Burns and stinging sensations may occur when using OVIDE Lotion. Apply OVIDE Lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp.

Pay particular attention to the back of the head and neck when applying OVIDE Lotion. Anyone applying OVIDE Lotion should wash hands immediately after the application process is complete. Allow hair to dry naturally and to remain uncovered.

Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing. Rinse hair and use a fine - toothed (nit) comb to remove dead lice and eggs. If lice are still present after 7 - 9 days, repeat with a second application of OVIDE Lotion.

Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment. Laboratory Tests There are no special laboratory tests needed in order to use this medication.

Carcinogenesis , Mutagenesis, and Impairment of Fertility Carcinogenesis, mutagenesis and impairment of fertility have not been studied with OVIDE Lotion (0.5% pharmaceutical grade malathion). However, following long-term oral administration of technical grade malathion to rodents via dietary supplementation, increased incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at malathion doses greater than 1500 mg/kg/day, and in female F344 rats dosed for 2 years at malathion doses greater than 400 mg/kg/day.

These tumors occurred only in association with severe hepatic toxicity and chronic suppression of acetylcholinesterase activity, or at doses causing excessive mortality. Based on body surface area, doses at which carcinogenic effects were observed in rodents following life-time exposures to malathion were approximately 14- to 26-fold greater than the maximum dose anticipated in a 10 kg child following a single use…

🤒 Adverse Reactions 49 words ▾

ADVERSE REACTIONS Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis. It is not known if OVIDE Lotion has the potential to cause contact allergic sensitization.

🤰 Pregnancy 110 words ▾

Pregnancy Pregnancy Category B There was no evidence of teratogenicity in studies in rats and rabbits at doses up to 900 mg/kg/day and 100 mg/kg/day malathion, respectively. A study in rats failed to show any gross fetal abnormalities attributable to feeding malathion up to 2,500 ppm (~ 200 mg/kg/day) in the diet during a three - generation evaluation period. These doses were approximately 40 to 180 times higher than the dose anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability).

Because animal reproduction studies are not always predictive of human responses, this drug should be used (or handled) during pregnancy only if clearly needed.

🧒 Pediatric Use 24 words ▾

Pediatric Use The safety and effectiveness of OVIDE Lotion in children less than 6 years of age has not been established via well-controlled trials.

🆘 Overdosage 111 words ▾

OVERDOSAGE Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle. Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion. Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.

🧬 Clinical Pharmacology 96 words ▾

CLINICAL PHARMACOLOGY Malathion is an organophosphate agent which acts as a pediculicide by inhibiting cholinesterase activity in vivo. Inadvertent transdermal absorption of malathion has occurred from its agricultural use. In such cases, acute toxicity was manifested by excessive cholinergic activity, i.e., increased sweating, salivary and gastric secretion, gastrointestinal and uterine motility, and bradycardia (see OVERDOSAGE ).

Because the potential for transdermal absorption of malathion from OVIDE Lotion is not known at this time, strict adherence to the dosing instructions regarding its use in children, method of application, duration of exposure, and frequency of application is required.

📦 How Supplied / Storage and Handling 40 words ▾

HOW SUPPLIED OVIDE ® (malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5293-4. Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Flammable. Keep away from heat and open flame.

📦 Storage and Handling 21 words ▾

Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Flammable. Keep away from heat and open flame.

📋 Description 64 words ▾

DESCRIPTION OVIDE Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of malathion is (±) - [(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C 10 H 19 O 6 PS 2 , and has the following chemical structure: Chemical Structure

💬 Information for Patients ~1 min read ▾

Information to Patients OVIDE Lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet.

The person applying OVIDE Lotion should wash hands after application. Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. OVIDE Lotion should only be used on children under the direct supervision of an adult.

Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet. In case of accidental ingestion of OVIDE Lotion by mouth, seek medical attention immediately. If you are pregnant or nursing, you should contact your physician before using OVIDE Lotion.

If OVIDE Lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur. If skin irritation occurs, wash scalp and hair immediately.

If the irritation clears, OVIDE Lotion may be reapplied. If irritation reoccurs, consult a physician. Burns and stinging sensations may occur when using OVIDE Lotion.

Apply OVIDE Lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying OVIDE Lotion. Anyone applying OVIDE Lotion should wash hands immediately after the application process is complete.

Allow hair to dry naturally and to remain uncovered. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing. Rinse hair and use a fine - toothed (nit) comb to remove dead lice and eggs.

If lice are still present after 7 - 9 days, repeat with a second application of OVIDE Lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51672-5292-03 · Sun 51672-5294-04 · Sun →
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.