FDA.reportPublic FDA data

Equaline

Manufacturer
SUPERVALU INC.
Effective date
2014-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:57

Label at a glance#

ProductEqualine Fast Acting
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

for the temporary relief of nasal congestion due to: • common cold • hay fever • upper respiratory allergies

Dosage and administration

• adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more than every 4 hours • children under 12 years of age: ask a doctor • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Storage and handling

• store between 20°-25°C (68°-77°F) • container is filled to proper level for best spray action

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies

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 exceed recommended dosage

• do not use for more than 3 days. Use only as directed

• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

• the use of this container by more than one person may spread infection

• frequent or prolonged use may cause nasal congestion to recur or worsen

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

  • adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more than every 4 hours
  • children under 12 years of age: ask a doctor
  • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

STORAGE AND HANDLING SECTION

  • store between 20°-25°C (68°-77°F)
  • container is filled to proper level for best spray action

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

1-877-932-7948

IMPORTANT: Keep this carton for future reference on full labeling

SPL UNCLASSIFIED SECTION

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

Distributed By: Supervalu Inc.
Eden Prairie, MN 55344

This product is not manufactured or distributed by Novartis Consumer Health Inc., the owner of the registered trademark 4-Way Fast Acting Nasal Spray.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-728-01

Equaline

Fast Acting

Nasal Spray

Phenylephrine hydrochloride 1%

(nasal decongestant)

fast acting relief of

  • nasal congestion
  • sinus congestion
  • sinus pressure
  • swollen nasal passages

1 FL OZ (30mL)

Equaline Nasal Spray
Equaline Nasal Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSN1
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD1
1087043phenylephrine hydrochloride 1 % Nasal SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41163-728-012020-01-31C16284748780-19d75b9d1-164d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-728-01EqualineFast Acting1 in 1 CARTONSPRAY11
41163-728-01EqualineFast Acting30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-728EQUALINE FAST ACTING (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [SUPERVALU INC.]1Legacy NDC, 2 package rows20141126_f0f547dd-892b-4f94-8c63-7f0b2470aa91.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-728-01ML - Milliliter41163-728f9e48a1a-291f-4429-98a0-b6c37d0e893c12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
41163-72841163-728-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 296 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SUBCUTANEOUS28 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / TOPICAL0.32 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, EMULSION / INTRAVENOUS0.62 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
f0f547dd-892b-4f94-8c63-7f0b2470aa91f0f547dd-892b-4f94-8c63-7f0b2470aa912014-11-03WarningsExact identifier
spl id: f0f547dd-892b-4f94-8c63-7f0b2470aa91
spl set id: f0f547dd-892b-4f94-8c63-7f0b2470aa91

Reported adverse events (FAERS/openFDA)#

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