MedPath

Marc Glassman

Marcs Glassman Nasal Oxymetazoline Spray Drug Facts

Approved
Approval ID

69503990-e489-48ad-b17c-4a9ac25a3463

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

MARC GLASSMAN, INC.

DUNS: 094487477

Products 1

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

oxymetazoline hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68998-715
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
oxymetazoline hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (10)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
OXYMETAZOLINE HYDROCHLORIDEActive
Quantity: 0.05 g in 100 mL
Code: K89MJ0S5VY
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Principal Display Panel

Marcs ®

NDC# 68998-715-30

Compare to the active Ingredient in Afrin® Original

Nasal Spray

Original 12 Hour Relief

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast, Powerful Congestion Relief

Colds & Allergies

Maximum Strength

1 FL OZ (30 mL)

**IMPORTANT:**Keep this carton for future reference on full labeling.

Distributed by:

Marcs Glassman, Inc.

West 130thStreet

Cleveland, OH 44130

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin ®Original.

Mracs Glassman Maximum Strength Nasal Spray

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/18/2019

Uses

  • for the temporarily relief of nasal congestion due to the, common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2019

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/18/2019

Purpose

Nasal Decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2019

Warnings

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/18/2019

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/18/2019

When using this product

*do not use more than directed

  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/18/2019

Stop use and ask a doctor if

symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/18/2019

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/18/2019

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/18/2019

Directions

***adults and children 6 to under 12 years of age (with adult supervision):**2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. ***children under 6 years of age:**ask a doctor

**To Spray:**squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/18/2019

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/18/2019

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/18/2019

Questions or comments?

1-866-467-2748

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