Get Compliant.

Personal Care, Cosmetics & OTCs sold in the United States

Deadline for MoCRA Cosmetic
Facility Registration:
December 31, 2023

Facility Registration
Cosmetic & OTC

FEI Number Registration
(For Manufacturers)
$400 $325

Cosmetic Facility Registration (MoCRA - Every 2 Years)
$500  $450

Cosmetic Facility Registration (MoCRA - Amended or Abbreviated Renewal)
$375   $350

*Drug Establishment Registration
(OTC Annual -  Initial)
$500  $450

*Supplement / Dietary Drugs Establishment Registration
COMING SOON

*Domestic Food Facility Registration
$500   $450

Hourly Consulting Fees
$150 /HR

*Costs are registration and US Agent services only and do not include any consulting needs or FDA fees.

Who Should Register?

Deadline for MoCRA Initial
Product  Registration:
December 31, 2023

Cosmetic FDA Registration

*Product Listing / US Agent (Initial)
1-5 products        $450   $425/SKU
6-10 products      $425   $400/SKU
11-20 products     $400  $375/SKU
21-30 products    $375   $350/SKU
31+ products        $350   $325/SKU

Product Listing (Annual Renewal)
  • 15% off initial listed price at time of renewal
Product Listing (Abbreviated Renewal or Off Schedule Update)
  • 10% off initial listed price at time of renewal
Label Review
(Legal or Formulation Expert)
$500-$800 /SKU

Website and Social Media Audit for Inappropriate Claims
$500-$1200

Hourly Consulting Fees
$150 /HR

Adverse Event Reporting or Product Recall Assistance
Inquire for pricing

California Safe Cosmetic Act Product & Ingredient Reporting
Inquire for pricing

INCI or CAS Registration
Inquire for pricing

*Costs are registration and US Agent services only and do not include any consulting needs or FDA fees.

**All SDS, COA, Testing Documentation must be provided. If not, Citron offers these services. See Formulation VIP Track for details. Documentation is a complimentary service for Salve Naturals customers.

Which Products Qualify?

FDA OTC Drug and
Medical Device Registration

OTC FDA Registration

Hourly Consulting Fees
(Project assessment, active ingredient determination and percentages, registration and labeling methodology, etc.)
$150 /HR

National Drug Code (NDC)
(Labeler Initial)
$500

Abbreviated New Drug Application (ANDA)
Inquire for pricing

New Drug Applications (NDA)
Inquire for pricing

*Drug Listing (OTC, Medical Device)
1-5 products       $450   $425/SKU
6-10 products     $425   $400/SKU
11-20 products    $400  $375/SKU
21-30 products   $375   $350/SKU
31+ products       $350   $325/SKU

Product Listing (Annual Renewal)
  • 15% off initial listed price at time of renewal
Product Listing (Abbreviated Renewal or Off Schedule Update)
  • 10% off initial listed price at time of renewal
Label Monograph Review
(OTC, Medical Device)
$500-$800 /SKU

Label Monograph Design
(OTC, Medical Device)
$500 /SKU

Adverse Event Reporting or Product Recall Assistance
Inquire for pricing

*Costs are registration services only and do not include any consulting needs or FDA fees.

Which Products Qualify?

Prices are subject to change. Promotional discount applies during Beta Testing soft launch.
Beta Testing Soft Launch: July 12, 2024 - December 31, 2024
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simplified fda compliance with citron.

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Please allow 2 business days for your FDA Registration Expert to be assigned to you.

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