NDC 0597-0151 Dulcoease Pink

Dulcoease Pink with NDC 0597-0151 is a a human over the counter drug product labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The generic name of Dulcoease Pink is docusate sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dulcoease Pink Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

• DOCUSATE SODIUM 100 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

• D&C RED NO. 33 (UNII: 9DBA0SBB0L)
• FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
• FD&C RED NO. 40 (UNII: WZB9127XOA)
• FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
• GELATIN (UNII: 2G86QN327L)
• GLYCERIN (UNII: PDC6A3C0OX)
• HYPROMELLOSES (UNII: 3NXW29V3WO)
• POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
• PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
• WATER (UNII: 059QF0KO0R)
• SORBITOL (UNII: 506T60A25R)
• SORBITAN (UNII: 6O92ICV9RU)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
• ISOPROPYL ALCOHOL (UNII: ND2M416302)
• MANNITOL (UNII: 3OWL53L36A)
• FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

• Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
Labeler Code: 0597
FDA Application Number: part334 What is the FDA Application Number?
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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
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.
Start Marketing Date: 02-01-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date: 11-30-2021 What is the End Marketing Date?
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.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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