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Equaline Nasal

SuperValu Inc. Nasal Spray Drug Facts

Approved
Approval ID

d7fa1720-eac4-4e82-9401-77215ce4f545

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

United Natural Foods, Inc. dba UNFI

DUNS: 943556183

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 Code41163-343
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Oxymetazoline hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (14)

OXYMETAZOLINE HYDROCHLORIDEActive
Quantity: .05 g in 100 mL
Code: K89MJ0S5VY
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
EUCALYPTOLInactive
Code: RV6J6604TK
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
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
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Package/Label Principal Display Panel

compare to Afrin® No Drip Severe Congestion active ingredient

EQUALINE®

no drip

nasal spray

oxymetazoline HCl 0.05% (nasal decongestant)

12 hour relief

severe congestion

pump mist

• for colds & allergies

• won’t drip from nose or down throat

• maximum strength plus menthol

• fast, powerful congestion relief

#1 Doctor recommended Adult Nasal Spray active ingredient

1 FL OZ (30mL)

![equaline-nasal-spray-carton-image.jpg](/dailymed/image.cfm?name=equaline- nasal-spray-carton-image.jpg&id=896017)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

temporarily relieves nasal congestion due to:

common cold

hay fever

upper respiratory allergies

temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes so you can breathe more freely

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/5/2016

Other information

store at 20-25°C (68-77°F)

retain carton for future reference on full labeling

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/5/2016

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/5/2016

Purpose

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/28/2024

Warnings

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

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

Stop use and ask a doctor if

symptoms persist

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/12/2025

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 Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/5/2016

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

1-855-423-2630

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