Ivermectin Lotion
NDC Package 51316-985-08

11-digit billing NDC: 51316098508
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ivermectin lotions is important: Read warnings before usechildren 6 months of age to under 12 years of age: an adult should supervise useadults and children 6 months of age and over:Inspectall household members should be checked by another person for lice and/or nits (eggs)use a magnifying glass in bright light to help you see the lice and/or nits (eggs)use a tool, such as a comb or two unsharpened pencils to lift and part the hairlook for tiny nits near the scalp, beginning at the back of the neck and behind the earsexamine small sections of the hair (1-2 inches wide) at a timeunlike dandruff, nits stick to the hair. This formulation utilizes a lotion delivery system. Marketed by Cvs Pharmacy, this product is identified by NDC 51316-985 and is authorized under FDA application ANDA210720.

Identification & Billing

NDC Package Code
51316-985-08
Package Description
1 TUBE in 1 CARTON / 117 g in 1 TUBE
Product Code
51316-985
11-Digit Billing Format
51316098508
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ivermectin
Non-Proprietary Name
Ivermectin
Substance Name
Ivermectin
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
IVERMECTIN 5 mg/g
Pharmacologic Class
Usage Information
Important: Read warnings before usechildren 6 months of age to under 12 years of age: an adult should supervise useadults and children 6 months of age and over:Inspectall household members should be checked by another person for lice and/or nits (eggs)use a magnifying glass in bright light to help you see the lice and/or nits (eggs)use a tool, such as a comb or two unsharpened pencils to lift and part the hairlook for tiny nits near the scalp, beginning at the back of the neck and behind the earsexamine small sections of the hair (1-2 inches wide) at a timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.if either lice or nits (eggs) are found, treat with productTreatyour hair and scalp must be DRY before applying product use the top of cap to break the tamper seal on the tubeapply product directly to dry hair and scalpcompletely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hairuse only amount needed to completely cover hair and scalp, up to 1 entire tube, and discard the remainingrub product throughout your hairit is important to completely cover your entire head so that all lice and eggs are exposed to the lotion. Be sure that each hair is coated from the scalp to the tip.Wait and rinseallow product to stay on your hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered your hair and scalp with product.after 10 minutes, rinse product completely from your hair and scalp using only waterafter rinsing, dry and style as usual. Wait 24 hours before applying shampoo.After treatmentwash your hands after applying productnit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nitsthis is a single use product. Discard tube after use.do not use again on the same person and same lice infestation without talking to a healthcare provider firstif infestation continues, see a doctor for other treatmentsmachine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice.

Regulatory & Marketing

Labeler Name
Cvs Pharmacy
Product Type
Human Otc Drug
FDA Application #
ANDA210720
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-20-2025
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51316-985-08 identifies a specific commercial package of 1 tube in 1 carton / 117 g in 1 tube of Ivermectin, a human over the counter drug labeled by Cvs Pharmacy. This lotion is formulated for topical use and contains ivermectin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cvs Pharmacy on June 20, 2025. The current certification is valid through December 31, 2027.

How is this Cvs Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316098508. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
51316-985-08
11-Digit CMS (5-4-2)
51316-0985-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.