Geoff LeCain

“The id with the root…along with the Establishment postal code (if any) along with the Establishment postal code (if any) and country must match the DUNS number, postal code and country in the Dun ...

“If the NDC Product Code was previously submitted, then the product and generic name, source, active ingredient UNII, dosage form, active ingredient strength, product characteristics of size, shape...

“If the document type is 34390-5 (Human OTC drug label) and the citation is not part352 (sunscreens), then there must be the following sections: 55106-9 (OTC- active ingredient section), 55105-1 (O...

“The id with the root…along with the Establishment postal code (if any) along with the Establishment postal code (if any) and country must match the DUNS number, postal code and country in the Dun ...

“If the code is C73603 (OTC monograph final) or C73604 (OTC monograph not final), then the id extension and active ingredient code must match the codes in the OTC validation-final list or the OTC v...

“You must create one or more sections with the LOINC "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL" at the bottom of the document and include the image(s) that best represent the product” This error is cr...

“id must not match any other id across all sections, documents, or any id other than the id of the same section previously submitted” This error is generated from a newer FDA validation rule that c...

“This submission ciXXXXXXXXXXXXX.XXX@llnap21_te experienced an internal processing error please contact the administrator.” This is likely an error with the ESG submission. We suggest contacting th...

“This submission ciXXXXXXXXXXXXX.XXX@llnap21_te.ZIP is incorrectly packaged, it is a bare file, not a directory. See section five of Step-by-Step Instructions for Creating Structured Product Labeli...

In a Word Document: Greetings,Here is feedback regarding your recent SPL submission:Core ID: ciXXXXXXXXXXXXX.XXX@llnap21_teErrors/Comments:- In the product data elements section, the basis of stren...