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KROGER No Drip Nasal Mist Severe Congestion

NO DRIP NASAL MIST SEVERE CONGESTION 1 FL OZ (30mL)

Approved
Approval ID

7256e048-ad69-4322-844d-872f05e6fc8a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

KROGER COMPANY

DUNS: 006999528

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 Code41226-718
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 (17)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
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
CAMPHOR, (-)-Inactive
Code: 213N3S8275
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
EUCALYPTOLInactive
Code: RV6J6604TK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/23/2024

Principal Display Panel

NDC 41226-718-30

*Compare to the active ingredient in Afrin ®No Drip Severe Congestion Pump Mist

No DRIP

NASAL MIST

Nasal Decongestant

Oxymetazoline HCl Nasal Solution

SEVERE CONGESTION

Pump Mist

Up to 12 Hours Relief

Won’t drip from nose or down throat

Fast, Powerful Congestion Relief

For Colds & Allergies

Maximum Strength plus Menthol

1 FL OZ (30 mL)

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

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

Distributed by:

*This product is not manufactured and distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Severe Congestion Pump Mist.

KROGER NO DRIP Severe Congestion Nasal Spray Pump Mist 1 FL OZ (30 mL)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/23/2024

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/23/2024

Active ingredient

Oxymetazoline hydrochloride 0.05%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/23/2024

Purpose

Nasal Decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 4/23/2024

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 at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/23/2024

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

Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim 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. Replace clip under rim and secure cap after use.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/23/2024

Other information

  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/23/2024

Inactive ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

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