60927-118 NDC - SMARTH ()

Drug Information

  • Product NDC: 60927-118
  • Proprietary Name: Smarth
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Carib Sales, LLC
Product Type:
FDA Application Number: part355
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:12/1/2013

Package Information

No. Package Code Package Description Billing Unit
160927-118-131 TUBE in 1 CARTON (60927-118-13) / 181 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC60927-118The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMESmarthThe translation of the dosage form Code submitted by the firm.
PROPRIETARY NAME SUFFIXExtra Strength WhiteningThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/1/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart355This 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.
LABELER NAMECarib Sales, LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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