50414-100 NDC - HAND GEL PROLIM INSTANT HAND SANITIZER ()

Drug Information

  • Product NDC: 50414-100
  • Proprietary Name: Hand Gel Prolim Instant Hand Sanitizer
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Prolim Quimica Avancada Ltda.
Product Type:
FDA Application Number: part333
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:3/10/2010

Package Information

No. Package Code Package Description Billing Unit
150414-100-0160 mL in 1 BOTTLE, PLASTIC (50414-100-01)
250414-100-0280 mL in 1 BOTTLE, PLASTIC (50414-100-02)
350414-100-03100 mL in 1 BOTTLE, PLASTIC (50414-100-03)
450414-100-04200 mL in 1 BOTTLE, PUMP (50414-100-04)
550414-100-05500 mL in 1 BOTTLE, PUMP (50414-100-05)
650414-100-061000 mL in 1 BOTTLE, PUMP (50414-100-06)
750414-100-075000 mL in 1 BOTTLE, PLASTIC (50414-100-07)
850414-100-081 BAG in 1 BOX (50414-100-08) / 800 mL in 1 BAG
950414-100-091 BAG in 1 BOX (50414-100-09) / 1200 mL in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC50414-100The 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.
PROPRIETARY NAMEHand Gel Prolim Instant Hand SanitizerThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/10/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT 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 NUMBERpart333This 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 NAMEProlim Quimica Avancada Ltda.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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