SPL Portal Help Document

Frequently Asked Questions

• CMO: Drug Manufactured Under Contract
• Windows 11 & SPL (update Microsoft Edge settings to view XML)
• What is SPL?
• Where do I find my OTC Monograph ID Number (Previously called OTC "Part Number"?
• Do I have to constantly save files from the Portal to my local machine?
• What does Pass/Fail Validation mean?

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ACA Samples

• Search Distributions
• ACA Samples
• Distribution Detail
• Practitioners
• Sample Packages
• Distributors

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Actions

• Sign Out
• Change Password
• Contact Us

Admin

• Groups
• Company Configuration
• Labeling Types
• Submission Type

Application Authentication

• Application Authentication

Forgotten Password

• Forgotten Password

Contacts & Entities

• Creating a Cosmetic Product Listing File
• Creating a Cosmetic Facility Registration File
• Data Validation
• Addresses
• Contacts
• Labelers

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NLM Labels

• Advanced Search
• NLM Labels
• NDC Search

Products

• Product List
• Products
• NDC Code Reservations / Reserved Marketing Status
• My Checked Out Products
• Product Licenses
• Creating a New Product

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Reports

• Reports

Submissions

• Requesting a New Submission
• Submissions
• Submit to FDA Gateway

Templates

• Assign Template to Labeling Type
• Templates

View

• View SPL/SPM File
• Announcements
• Help Files