NDC 87276-003-01 HUMAN OTC DRUG

Drug Status:  Active

Proprietary Name: Ivometn Ivermectin Lice Treatment

Drug Overview

The NDC Code 87276-003-01 is assigned to “Ivometn Ivermectin Lice Treatment ” (also known as: “Ivermectin”), a human otc drug labeled by “Shenzhen Zhenshangzekai 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	87276-003-01
	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	87276-003
	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	87276-0003-01
	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	Ivometn Ivermectin Lice Treatment
	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 Zhenshangzekai 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	Directions Important: Read warnings before use .Children 6 months of age to under 12 years of age : an adult should supervise use Adults and children 6 months of age and over: Inspect All houschold members should be checked by anothe!person for lice and/or nits (eggs) Use a magnifying glassin bright light to help you see thelice and/or nits(eggs) Use a tool, such as a comb or two unsharpened pencilsto lift and part the hair Look for tiny nits near the scalp, beginning at the backof theneck and behind the ears Examine small sections ofthe hair (1-2 inches wide) ata time .Unlike dandruff, nits stick to the hair, Dandruff shouldmove when lightly touched If either lice or nits (eggs) are found, treat with product Treat Your hair and scalp must be DRY before applyingproduct Apply the product directly onto dry hair and scalp Completely cover your scalp and hair closest to thescalp first.and then apply outwards towards the endsofyour hair Use only as much asneeded to fully cover hair andscalp up to one full bottle, and discard the remainingRub product throughout your hair Itis important to completely cover your entire head sothat all lice and eggs are exposed to the lotion, Be surethat each hair is coated from the scalp to the tip Wait and Rinse Allow product to stay on your hair and scalp for 10minutes after it has been applied, Use a timer or clockStart timing after you have completely covered yourhair and scalp with product. After 10 minutes, rinse product completely from youhair and scalp using only water. After rinsing, dry and style hair as usual. Wait 24 hoursbefore applying shampoo. After treatment. Wash your hands after applying product. -Nit combing is not necessary whentreating with product for it to work, but ifdesired, a fne-tooth comb or special nitcomb may be used to remove dead liceand nits.This is a single use product, Discard bottle after use.Do not use again on the same personand same lice infestation without talkingto a healthcare provider frst.If infestation continues, see a doctor forother treatments. Machine wash any bedding and clothingused by anyone having lice, Machinewash at high temperatures (150°F) andtumble in a hot dryer for 20 minutes.After fnishing treatment with licemedicine, check everyone in your famillyfor lice after one week. Considertreatment 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	87276-003-01
	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 G IN 1 BOTTLE (87276-003-01)
	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	20251210
	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	87276-003
	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	M031
	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	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20251210
	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	2025-12-16
	The date that a record was last updated or changed.