The SPL Engine.
Complete FDA drug establishment registration and product listing. We handle the XML complexity, NDC assignment, and annual renewals so you don't have to.
NDC Architecture.
4-4-2? 5-3-2? 5-4-1? The National Drug Code (NDC) format is permanent. Choosing the wrong structure can block future product launches. We help you architect a scalable NDC strategy from Day 1.
OTC Monograph M020
Sunscreen Drug Products for Over-the-Counter Human Use
Monograph
Intelligence.
Is your sunscreen GRASE (Generally Recognized As Safe and Effective)? Our system matches your active ingredients against FDA Final Monographs to confirm OTC eligibility before you list.
From Concept to DailyMed.
We manage the entire chain: obtaining your Labeler Code, generating the SPL file, submitting via the ESG gateway, and verifying publication on DailyMed.
Expected: ZINC OXIDE (UNII: SOI2LOH54Z)
The SPL Validator.
FDA rejects thousands of listings for XML syntax errors or UNII code mismatches. Our validator pre-checks your data against FDA's schema to ensure first-pass acceptance.
Foreign Manufacturer?
We link it.
Importing drugs to the US? You need a US Agent and a compliant establishment registration. We handle the cross-border linkage to prevent “Unapproved Drug” detentions at customs.
Your Labeler Code.
The first 5 digits of your NDC identify your company forever. We manage the application process to get your code assigned correctly the first time.
Private Label
Infrastructure.
Launching a brand using a contract manufacturer? You need a “Private Label Distributor” listing. We coordinate with your CMO to link their facility to your brand's NDC without exposing your supplier.
The Oct-Dec Crunch.
Drug establishments must renew every year between October 1 and December 31. Assurentry automates this, ensuring you never wake up to an “Inactive” status on January 1st.
Full Lifecycle Management
From Labeler Code to Annual Renewal, we handle every step.
SPL Conversion
We convert your data into FDA's required XML format.
Annual Renewal
Mandatory renewal period Oct 1 - Dec 31 managed automatically.
Blanket No-Change
One-click certification for unchanged product listings.
Platform vs. Government Portal.
CDER Direct is a raw data entry form. Assurentry is a compliance engine that catches errors before you submit.
Master the SPL.
Stop fighting with XML. Generate compliant drug listings in minutes.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.