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Primatene Mist

Epinephrine Inhalation · Aerosol

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Primatene Mist
Generic name
Epinephrine Inhalation
Dosage form
Aerosol
Route
Respiratory (Inhalation)
Marketing category
NDA · NDA
Labeler
Armstrong Pharmaceuticals, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Epinephrine 125 ug/1 2693442 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Aerosol
Route of administration
Respiratory (Inhalation)
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha-Agonists [MoA] MoA All 85 members
Adrenergic beta-Agonists [MoA] MoA All 37 members
Catecholamine [EPC] EPC All 39 members
Catecholamines [CS] CS All 41 members
alpha-Adrenergic Agonist [EPC] EPC All 85 members
beta-Adrenergic Agonist [EPC] EPC All 37 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205920
Application type
NDA · New Drug Application
Approval date
November 7, 2018
Sponsor
ARMSTRONG PHARMS
Products on application
1
Submissions recorded
1
Products approved under application 205920.
Product Trade name Form Strength Ingredient Status TE Flags
205920-001 PRIMATENE MIST AEROSOL, METERED EPINEPHRINE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8367734 January 26, 2026 001 No December 17, 2018

Approval history

Source: Drugs@FDA
Most recent submissions on application 205920.
Type No. Action Status Date Review
Original application 1 Type 5 - New Formulation or New Manufacturer Approved November 7, 2018 Standard

Review documents

  • 0 · Original application · June 3, 2019
  • 0 · Original application · November 8, 2018
  • 0 · Original application · November 8, 2018

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260616). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260616

Indications and Usage

openFDA Drug Labeling

Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath

Purpose Bronchodilator

Dosage and Administration

openFDA Drug Labeling

Directions ■ read the Consumer Information Insert for detailed directions on how to use this product ■ do not use more than directed ■ for adults and children 12 years of age and over ■ children under 12 years of age: do not use; it is not known if the drug works or is safe in children under 12 Before first use (new inhaler) activate new inhaler by shaking then spraying into air 4 separate times each time you dose ■ remove red cap (if attached) ■ shake then spray into the air 1 time ■ exhale completely, place inhaler in mouth ■ inhale deeply while pressing down on top of inhaler, then continue the deep breath ■ hold breath as long as possible, exhale ■ wait 1 minute. If symptoms not relieved, take a second inhalation by repeating steps above. after use ■ wait at least 4 hours between doses ■ do not use more than 8 inhalations in 24 hours ■ wash inhaler after each day of use. Run water through the mouthpiece for 30 seconds.

Warnings For oral inhalation only Asthma alert: Because asthma may be life threatening, see a doctor if you ■ are not better in 20 minutes ■ get worse ■ need more than 8 inhalations in 24 hours ■ have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. Do not use ■ unless a doctor said you have asthma ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. Ask a doctor before use if you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ thyroid disease ■ seizures ■ narrow angle glaucoma Ask a doctor or pharmacist before use if you are ■ taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions ■ taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) When using this product ■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. ■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose. ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect ■ avoid spraying in eyes ■ contents under pressure. Do not puncture or incinerate. ■ do not store near open flame or heat above 120°F (49°C). May cause bursting. Stop use and ask a doctor if ■ your asthma is getting worse (see asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure If pregnant or breast-feeding , ask a health care professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use ■ unless a doctor said you have asthma ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have ■ ever been hospitalized for asthma ■ heart disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ thyroid disease ■ seizures ■ narrow angle glaucoma

Stop use and ask a doctor if ■ your asthma is getting worse (see asthma alert) ■ you have difficulty sleeping ■ you have a rapid heart beat ■ you have tremors, nervousness, or seizure

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Epinephrine 0.125 mg

Adverse event reports

Source: openFDA FAERS
112,597
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: EPINEPHRINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
17270-5512-0 17270-5512 Armstrong Pharmaceuticals, Inc. 12 CARTON in 1 PACKAGE (17270-5512-0) / 1 INHALER in 1 CARTON / 160 AEROSOL in 1 INHALER June 9, 2026
17270-5530-0 17270-5530 Armstrong Pharmaceuticals, Inc. 1 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER December 14, 2018
17270-5512 17270-5512 Armstrong Pharmaceuticals, Inc. — December 14, 2018
17270-5530 17270-5530 Armstrong Pharmaceuticals, Inc. — December 14, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.