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  4. NDC Product Code: 21695-887 Infants Silapap

NDC 21695-887 Infants Silapap

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 21695-887?
  5. Infants Silapap Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
21695-887
Proprietary Name:
Infants Silapap
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
21695
Product Label ID:
0924758b-9d8c-490a-a8b3-56b5aee12962
FDA Application Number: [6]
part343
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date: [9]
04-01-1997
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Flavor(s):
CHERRY (C73375 - WILD CHERRY)

Code Structure Chart

Product Details

What is NDC 21695-887?

The NDC code 21695-887 is assigned by the FDA to the product Infants Silapap which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 21695-887-15 15 ml in 1 bottle, dropper , 21695-887-30 30 ml in 1 bottle, dropper . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Infants Silapap?

■ this product does not contain directions or complete warnings for adult use■ do not give more than directed (see overdose warning)■ find right dose on chart, if possible use weight to dose; otherwise, use age■ use only enclosed dropper designed for use with this product, do not use any other dosing device■ fill to dose level■ dispense liquid slowly into child's mouth, toward inner cheek■ may be given alone or mixed with formula, milk, juice etc.■ If needed, repeat dose every 4 hours■ do not give more than 5 times in 24 hours■ Replace dropper tightly to maintain child resistanceWeight (lb)Age (yr)Dose (mL)under 24under 2 yearsask a doctor24-352-3 years 1.6 mL (0.8 + 0.8 mL)For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Other information Store between 20° - 25°C (68° - 77°F)

Which are Infants Silapap UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Infants Silapap Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Infants Silapap?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] 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".