MedPath

Equate Nasal

Wal-Mart Nasal Spray Drug Facts

Approved
Approval ID

c38a2783-aed9-466d-8976-59d03a792c04

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Wal-Mart Stores Inc

DUNS: 051957769

Products 1

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

Oxymetazoline HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49035-388
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Oxymetazoline HCl
Product Specifications
Route of AdministrationNASAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (11)

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
OXYMETAZOLINE HYDROCHLORIDEActive
Quantity: 0.05 g in 100 mL
Code: K89MJ0S5VY
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/22/2019

Principal Display Panel

Compare to Afrin® No Drip Active Ingredient

Original

No Drip

Nasal Spray

Oxymetazoline HCl 0.05%/Nasal Decongestant

Pump Mist

Fast, powerful congestion relief

Won't drip down your nose or throat

For colds and allergies

#1 Doctor recommended Adult Nasal Spray active ingredient

Maximum Strength

12 HOUR RELIEF

1 FL OZ (30 mL)

Nasal Spray Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/5/2015

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/25/2010

Inactive ingredients

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

WARNINGS SECTION

LOINC: 34071-1Updated: 7/10/2018

Warnings

Ask a doctor before use if you have

heart disease

thyroid disease

high blood pressure

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).

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/10/2018

Questions or comments?

1-888-287-1915

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/5/2015

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/25/2010

Purpose

Nasal decongestant

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/10/2018

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 metered 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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/10/2018

Other information

store at 20-25°C (68-77°F)

retain carton for future reference on full labeling

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Equate Nasal - FDA Drug Approval Details