MedPath

SYBORG SALTS Smelling Salt

SYBORG SALTS SMELLING SALTS

Approved
Approval ID

b9a9d589-00ef-4464-9a50-985d0d71664f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Direct Outlet Supplier LLC

DUNS: 133619845

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ammonium Carbonate and Sodium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85813-001
Product Classification
G
Generic Name
Ammonium Carbonate and Sodium Carbonate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (3)

AMMONIUM CARBONATEActive
Quantity: 15 g in 100 g
Code: NJ5VT0FKLJ
Classification: ACTIM
SODIUM CARBONATEActive
Quantity: 10 g in 100 g
Code: 45P3261C7T
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Syborg New Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/25/2025

Usage

The combination of Ammonium Carbonate + Sodium Carbonate added with some water and well shaken will release ammonia gas that irritates the nasal pathways that provides instant fight or flight with boosts in strength, endurance and focus.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/3/2025

Active Ingredients

Ammonium Carbonate................15%
Sodium Carbonate......................10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/25/2025

Purpose

The purpose of Syborg Smelling Salts is a boost of arousal in your respiratory system which causes the muscles that control breathing to be fast acting and put you into a fight or flight state whether its for training, working or when it matters the most The purpose of Syborg Smelling Salts is a boost of arousal in your respiratory system which causes the muscles that control breathing to be fast-acting and put you into a fight or flight state whether its for training, working or when it matters the most Game Time.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/25/2025

Warning and Precautions

Keep away from fire or flame
Always keep bottle 6 inches from nose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/25/2025

Keep away from children.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/25/2025

Do not use if allergic to any ingredients or pregnant.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/25/2025

Directions

Product is already pre-activated. Just shake the bottle and sniff!

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/3/2025

Inactive Ingredient

Alcohol

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/3/2025

Disclaimer

This drug has not been found to be safe by the FDA and effective and this labeling has not been approved by the FDA. This product is not intended to diagnose, treat or cure any disease

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

SYBORG SALTS Smelling Salt - FDA Drug Approval Details