New CoViD-19 SPL Templates
  • Keeping the recent CoViD-19 outbreak in our minds, we have added 4 new templates to SPL XForms for speeding up the process of preparing the SPL files:
    1. Alcohol 80% - Hand Sanitizer - CoViD-19 Emergency
    2. Isopropyl Alcohol 75% - Hand Sanitizer - CoViD-19 Emergency
    3. Alcohol 80% - Hand Rub - CoViD-19 Emergency
    4. Isopropyl Alcohol 75% - Hand Rub - CoViD-19 Emergency
  • You can load the appropriate template, while the procedure to fill up the form and preparing the SPL files remains same, we have filled up some of the fields in above templates which is common for all such products. You may review and keep it or modify according to your need.

Package Label Image Templates

New templates: now with automatic EAN-13 barcode generator

Download the templates and follow instructions given inside.
Disclaimer: We have provided these templates to help the users speed up the process but verifying and modifying the information remains the responsibility of the users.

Detailed instructions for using the CoViD-19 templates
  1. To proceed, you must have at least one DUNS number. You should have one DUNS number for each of your facilities, including your "head quarter" location. Over The Web: https://fedgov.dnb.com/webform or by Toll-Free Telephone: 1-(866) 705-5711 (tell the operator that you are applying to a "Federal financial assistance program" and need to register for a DUNS number.)

  2. Before submitting the SPL file, please make sure that you are registered successfully with Pragmatic ESG

    1. fill out the online form, make sure you have your DUNS number (see previous step).
    2. put all your DUNS numbers into the DUNS number field, separated by space, no comma.
    3. if you already have an NDC Labeler Code, do not forget to add it in the appropriate field.
    4. You will receive an email with a PDF file with terms and conditions and a last page for signatures.
    5. if you do not receive the email instantaneously, check your spam folder, and make sure that pragmaticdata.com is whitelisted in any spam blocker, it is critical that your corporate IT and email provider does not block our email.
    6. Print the last page on your company letterhead (do not print it only on white paper, you should have a company letter head and you should use it!
    7. Sign the page, and have a company official / officer sign to validate you as the contact person.
    8. Scan that signature page and attach to a simple email according to the instructions, and return it. Please make sure that your email is not adding images in signatures to your email. (You should not fail to print the page on company letter head, but then have a "letter head" for emails). If your email program automatically adds these images, you can usually choose Options -> Delivery Format -> Plain Text Only, to only add the attachment. You do not need to say anything in the email body.
    9. You should then immediately receive an acknowledgement informing you that your application has been tentatively approved.
    10. This above process is a very fast turn around from our automated system. If your systems do not blacklist our email and if you can make a reasonable scan (or use electronic document signing) and produce a reasonable one page PDF attachment, and send in an email without any other images, the process should take only minutes.

  3. If you do not have an NDC Labeler code, go to the SPL XForms, create an NDC labeler code request.

    1. Fill out your company head quarter location data
    2. The Pragmatic ESG registered user must be the contact person, especially the email must be the same, your company name should also be spelled exactly the same.
    3. Delete the field for the NDC labeler code, because you do not have any labeler code yet
    4. Validate the form so it is without error
    5. Submit to FDA
    6. You should receive a reply from FDA very soon, possibly within the same business day, that email from FDA will inform you of your labeler code.
    7. Go back to the form and load the same labeler code request file, either from where you had saved it (in your downloads folder probably) or the copy that was attached from your first email from Pragmatic Data ("According to our records you have submitted ...").
    8. Fill in your new labeler code in the labeler code field that you add back.
    9. Check all your data, especially be sure your DUNS number is the right one, it should be the head quarter DUNS, rather than the DUNS of any one of your facilities. It makes it much easier for you that way.
    10. Validate and submit to FDA
  4. Create an Establishment Registration for your production facilities. Use the Establishment Registration template on the form. Use your head quarter DUNS and your contact as per ESG registration as the Registrant. Add all your production facilities under that Registrant. Validate and submit to FDA.

  5. Now finally go to the one of the Alcohol or Isoporpyl Alcohol CoViD19 templates and

    1. Under the Header tab, fill out your head quarter DUNS as the labeler
    2. add the establishment(s) that is/are involved in the production of this (line of) products
    3. Under the Data Elements tab, fill out your product data and package data, make sure you choose an NDC code scheme that you can stick to. This is important, you will have received a 5-digit labeler code, so you have a choice, either 3 digits for products and 2 for package (5-3-2, 00000-000-00) or 4 digits for products and 1 for package (5-4-1 00000-0000-0). We recommend you decide as follows: if your company tends to make a large variety of products (up to 10 thousand products), yet produces them mostly in large quantities to the wholesale market (less than 10 different package sizes), then choose the 5-4-1 format. But if you tend to make no more than 1000 products yet likely provide them to the retail market at various package sizes, then chose the 5-3-2 format.
    4. You should also have already prepared your principle package / container labels, i.e., what you stick onto the bottles. If you have those images, save them as JPG files in reasonable size, i.e., if you have high resolution print files, take a screen shot where all font is still readable, and cut the screen shot in a simple image processing program and save as JPG file.
    5. If you do not have any container labels yet, you may use the Word files as templates, which are referenced from our CoViD19 help tab. You can add your proprietary names and company name / logo as you wish and you should add your full NDC code, the same as you put into the data elements.
    6. You attach these JPG files by selecting them under the principal container label section, and then actually insert them in the text box, by selecting the Image icon (that little tree image) and select the image file you had added.
    7. Validate everything
    8. Submit to FDA
NDC code scheme and barcodes

More details on NDC code scheme and barcodes

  • Once you have your labeler code, you decide what NDC format you want to use.One simple thing to do is just enumerate everything sequentially. Say your labeler code is 98765 you would say: 98765-001 - first product, 98765-002 - second product, 98765-003 - third product, ..., 98765-999 - 999th product
  • you could even use 98765-000 - for your first or 1000s product. And you do not need to be sequential at all. You can just use a dice and roll random digits. As long as you keep track!
  • Packages in the same way: 98765-001-01 - first package of first product, 98765-001-02 - second package of first product, ..., 98765-001-99 - 99th package of first product
  • Since there are so many possible combinations, you could even use the two digits differently. 98765-001-00, -01, -02, ..., -09 for the sizes of immediate containers, bottles, etc. 98765-001-11, -21, -31, ..., -91 for bundles, cartons, boxes, pallets, of those immediate bottles. It's all up to you, just giving some ideas here.

  • NDC codes are drop-in codes for UPC barcodes, you can put them in barcodes and you have all your retail items and shipping bundles uniquely coded.