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Nasal Spray, Lil Drug Store

Nasal Spray, 1oz

Approved
Approval ID

3ea06e88-a2c6-621b-e063-6294a90a1075

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

Lil' Drug Store Products, Inc.

DUNS: 093103646

Products 2

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

Oxymetazoline Hydrochloride 0.05% solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66715-6760
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Oxymetazoline Hydrochloride 0.05% solution
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (10)

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

Oxymetazoline Hydrochloride 0.05% solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66715-5460
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Oxymetazoline Hydrochloride 0.05% solution
Product Specifications
Route of AdministrationNASAL
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (10)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/1/2025

PDP/Package - Circle K™

FAST, POWERFUL CONGESTION RELIEF
** FOR COLD AND ALLERGIES**
Compare to the active ingredient
inAFRIN****®**** Original*

[Circle K logo) original ** nasal spray** ** Oxymetazoline HCI 0.05%** ** Nasal Decongestant** 1 fl oz (30 mL) PDP/Package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2025

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 10/1/2025

Other information

​Other information

  • store at room temperature
  • Keep this carton for future reference on full labeling.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2025

Active ingredient

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Purpose

Nasal Decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 10/1/2025

Warnings

Warnings

Ask a doctor before use

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

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

Stop use and ask a doctor ifsymptoms persist.

If pregnant or breast feeding

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

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: 10/1/2025

Directions

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: Push firmly down on cap and turn counter-clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2025

Inactive ingredients

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: 10/1/2025

Questions?

Questions?****
** call toll-free 1-877-507-6516**
(M-F 8AM-4:30PM CST)

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Nasal Spray, Lil Drug Store - FDA Drug Approval Details