NDC 50138-018-35 BULK INGREDIENT - ANIMAL DRUG

Drug Status:  Unfinished

Proprietary Name: Iodine

Drug Overview

The NDC Code 50138-018-35 is assigned to “ ” (also known as: “Iodine”), a bulk ingredient - animal drug labeled by “Ecolab Inc.”. The product's dosage form is solution, concentrate.

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Drug Information
NDC Package Code	50138-018-35
	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	50138-018
	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	50138-0018-35
	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.
Non Proprietary Name	Iodine
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	BULK INGREDIENT - ANIMAL 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	Ecolab Inc.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Unfinished
	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. ECO-DINE CONCENTRATE MUST BE DILUTED BEFORE USE. DO NOT MIX WITH ANYTHING BUT COOL, POTABLE WATER. FOR USE ONLY IN A DISPENSING SYSTEM RECOMMENDED BY ECOLAB Dilution Parameter(s). IMPORTANT: Never use concentrated product on teats.  Once concentrated teat dip product has been properly diluted, do not further dilute with water or mix with any other teat dips.  If product in dip cup becomes visibly dirty, discard contents and replenish with fresh product.  Do not reuse or return any unused product to the original container. Udder Prep:  When using an udder wash step before milking, make sure to wash teats with appropriate udder wash solution using proper cleaning procedures.  Teats should then be dried with single-service towels. Application of Diluted Eco-Dine Concentrate. Directions for Teat Dipping. Pre-Milk Dipping:  Before each cow is milked, and using fresh final RTU product dip each teat full-length into the teat dip cup.  Wipe teats after dipping using single-service towels to avoid contamination of milk. Post-Milk Dipping: Using fresh final RTU product dip each teat full-length into the teat dip cup.  Do not wipe. Allow to air dry.  Do not turn cows out in freezing weather until the product is completely dry. Directions for Teat Spraying. Pre-Milk Spraying: Before each cow is milked, and using fresh final RTU product spray entire teat.  Wipe teats after dipping using single-service towels to avoid contamination of milk. Post-Milk Spraying: Using fresh final RTU product spray entire teat immediately after each milking.  Do not wipe. Allow to air dry.  Do not turn cows out in freezing weather until the product is completely dry. Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving. PRECAUTION: Eco-Dine Concentrate is not intended to cure or help the healing of chapped or irritated teats.  As with any germicide, irritation or sensitization may occur in sensitive animals.  In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian. Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.
	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	SOLUTION, CONCENTRATE
	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	N/S (NOT SPECIFIED)
	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	N/S (NOT SPECIFIED)
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	IODINE (Substance Adverse Reports) - 40 mg/mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	50138-018-35
	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	2000000 ML IN 1 CONTAINER (50138-018-35)
	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/S (NOT SPECIFIED)
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N/S (NOT SPECIFIED)
	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	15-NOV-19
	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	50138-018
	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	N/S (NOT SPECIFIED)
	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	DRUG FOR FURTHER PROCESSING
	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	20251231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20191115
	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/S (NOT SPECIFIED)
	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	2025-04-29
	The date that a record was last updated or changed.