NDC 87782-001-02 HUMAN OTC DRUG

Drug Status:  Active

Proprietary Name: Synthabio Ivermectin

Drug Overview

The NDC Code 87782-001-02 is assigned to “Synthabio Ivermectin ” (also known as: “Ivermectin”), a human otc drug labeled by “Shenzhen Xuyan Technology Co., Ltd.”. The product's dosage form is lotion, and is administered via topical form.

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Drug Information
NDC Package Code	87782-001-02
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	87782-001
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	87782-0001-02
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Synthabio Ivermectin
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Ivermectin
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN OTC DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Shenzhen Xuyan Technology Co., Ltd.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Indication And Usage	Important: Read warnings before use. Age supervision. Children 6 months to under 12 years: an adult should supervise use. Adults and children 6 months and over: use as directed. Inspect. Have another person check all household members for lice and/or nits (eggs). Use a comb or two unsharpened pencils to lift and part the hair. Look for tiny nits near the scalp, beginning at the back of the neck and behind the ears. Examine small sections of hair (1–2 inches wide) at a time. Unlike dandruff, nits stick to the hair. Dandruff moves when lightly touched. If lice or nits are found, treat with this product. Treat. Hair and scalp must be dry before applying product. Use the top of the cap to break the tamper seal on the tube. Apply product directly to dry hair and scalp. Wait and rinse. Leave product on hair and scalp for 10 minutes after application. Use a timer or clock. Start timing after you have completely covered your hair and scalp. After 10 minutes, rinse product completely from hair and scalp using only water. After rinsing, dry and style as usual. Wait 24 hours before applying shampoo. After treatment. Wash hands after applying the product. Not combing is not necessary for the product to work. If desired, use a fine-tooth comb or special nit comb to remove dead lice and nits. This is a single-use product. Discard tube after use. Do not use again on the same person for the same lice infestation without talking to a healthcare provider first. If infestation continues, see a doctor for other treatments. Machine wash any bedding and clothing used by anyone with lice. Wash at high temperature (150°F) and tumble in a hot dryer for 20 minutes. After finishing treatment, check everyone in your family for lice after one week. Consider treatment for those who have lice.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	LOTION
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	TOPICAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	ANTIPARASITIC [EPC], PEDICULICIDE [EPC]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	IVERMECTIN (Substance Adverse Reports) - .5 g/100g
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	87782-001-02
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	1 TUBE IN 1 BOX (87782-001-02) / 117 G IN 1 TUBE (87782-001-01)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20260612
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	87782-001
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	M024
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	OTC MONOGRAPH DRUG
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20271231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20260612
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2026-06-24
	The date that a record was last updated or changed.