FDA.reportPublic FDA data

Extra Strength Nasal

Manufacturer
CVS PHARMACY
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-21 02:01:49

Label at a glance#

ProductExtra Strength Nasal
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies (allergic rhinitis) temporarily relieves sinus congestion and pressure shrinks swollen membranes so you can breathe more freely temporarily restores freer breathing through the nose

Dosage and administration

to spray, squeeze bottle quickly and firmly adults and children 12 years older: 2 or 3 sprays in each nostril not more often than every 4 hours. children under 12 years : ask a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine Hydrochloride 1.0 %

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies (allergic rhinitis)
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen membranes so you can breathe more freely
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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 may occur such as burning, stinging, sneezing and increase in nasal discharge
  • use of this container by more than one person may spread infection

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • to spray, squeeze bottle quickly and firmly
  • adults and children 12 years older:2 or 3 sprays in each nostril not more often than every 4 hours.
  • children under 12 years :ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, benzalkonium chloride, benzyl alcohol, purified water, sodium chloride, sodium citrate

Questions

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Extra Strength Neo-Synephrine ®*

Extra Strength

Nasal Spray

Phenylephrine hydrochloride 1.0 %

Nasal Decongestant

NON-DROWSY

COLD+ALLERGY

Nasal Congestion RELIEF

You can use every 4 hours

Fast Relief Of:

Sinus Congestion & Pressure

  • Colds, Allergies

*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Extra Strength Neo-Synephrine ®.

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

Do not use if printed seal over cap is torn or missing

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2021 CVS/pharmacy, CVS.com ®

1-800-SHOP CVS V-12431

CVS Quality Money Back guarantee

* This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine ®Extra Strength.

Package Label for Extra Strength Nasal Spray

Extra Strength Nasal Spray
Extra Strength Nasal Spray

Package Label for Extra Strength Sinus Relief

SPL UNCLASSIFIED SECTION

Extra Strength Sinus Relief Cold and Allergy Relief
Extra Strength Sinus Relief Cold and Allergy Relief

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428392591GTIN-13: 0050428392591
EAN-13: 0050428392591
GTIN-12: 050428392591
UPC-A: 050428392591
GTIN storage (14 digits): 00050428392591		Equaline Nasal Spray.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-44369842-443-30, 69842-443-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-09full-release2026-06-01 01:21:19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
ndc (package): 69842-443-40
ndc (package): 69842-443-30
ndc (product): 69842-443
ndc11 (package): 69842044330
ndc11 (package): 69842044340
spl id: 5950daff-d1dd-75fa-e063-6394a90a95be
spl set id: 7acf1a9a-bd97-48bb-8025-ac26070378a2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.