MedPath

Smelling Salts

85839-005 Smelling Salts

Approved
Approval ID

3874ec89-0f1d-87b9-e063-6394a90a300a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 3, 2025

Manufacturers
FDA

Shenzhen Finona Information Technology Co., Ltd

DUNS: 511271543

Products 1

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

Ammonia

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85839-005
Application NumberM011
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ammonia
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 3, 2025
FDA Product Classification

INGREDIENTS (4)

COTTONInactive
Code: 70LDW53ROO
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
AMMONIAActive
Quantity: 0.15 g in 1 g
Code: 5138Q19F1X
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/26/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/26/2025

For the temporary stimulation of the senses to restore alertness.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/26/2025

Ammonia 15%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/26/2025

Keep out of reach of children. lfswallowed, get medical
help or contact a Poison Control centerimmediately at
1-800-222-1222

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/26/2025

Inhalant

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/26/2025

It you have respiratory conditions such as asthma oremphysema.
If you have heart disease or high blood pressure.
If you are allergic to ammonia or strong odors.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/26/2025

For inhalation use only.

Do not ingest or apply to skin.
Avoid direct contact with eyes. lf contact occurs, rinsethoroughly with water for 15 minutes.
Use only as directed. Misuse may be harmful.
Use in a well-ventilated area. Do not use in enclosed spaces.
Prolonged exposure may cause irritation, Discontinue use if discomfort occurs.
Possible side effects include nasal irritation, coughing, or shortness of breath. lf symptoms persist, discontinue use and consult a doctor.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/26/2025

Avoid contact with eyes, ears, and mouth.
lf product gets into eyes, rinse thoroughly with water for 15 minutes.
Stop use and ask a doctor ifirritation or rash occurs.
These may be signs of a serious condition.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/26/2025

Hold bottle 10-15 cm (4-6 inches) from nostrils.
Inhale gently. Do not place directly inside the nostrils.
Do not inhale for more than 2 seconds per use.
Do not use more than once every 60 minutes.
Do not use more than 10 times per day.
Use only as needed. lfsymptoms persist, consult ahealthcare professional

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/26/2025

Alcohol
Cotton
Peppermint Oil

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Smelling Salts - FDA Drug Approval Details