FDA.reportPublic FDA data

Topcare Nasal Four

Manufacturer
Topco Associates LLC
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:27:42

Label at a glance#

ProductTopcare Nasal Four
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies

Dosage and administration

• adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours • children under 12 years: 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 at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  1. temporarily relieves nasal congestion due to:
  2. common cold
  3. hay fever
  4. upper respiratory allergies

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  1. heart disease
  2. diabetes
  3. thyroid disease
  4. high blood pressure
  5. trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  1. do not use more than directed
  2. do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
  3. use only as directed
  4. temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  5. 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

  1. adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
  2. children under 12 years: ask a doctor
  3. 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

  1. store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO 4-WAY® FAST ACTING NASAL SPRAY ACTIVE INGREDIENT

FAST ACTING

Nasal Four

NASAL SPRAY

NASAL DECONGESTANT

PHENYLEPHRINE HCl 1%

FAST RELIEF OF:

1 Nasal Congestion

2 Swollen Nasal Membranes

3 Sinus Congestion

4 Sinus Pressure

1 FL OZ (30 mL)

Nasal Four Carton
Nasal Four Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087043phenylephrine HCl 1 % Nasal SprayPSN6
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD6
1087043phenylephrine hydrochloride 1 % Nasal SpraySY6

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-648-10Topcare Nasal Four1 in 1 CARTONSPRAY16
36800-648-10Topcare Nasal Four30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-648TOPCARE NASAL FOUR (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 2 package rows20241022_99bc8829-167b-4cf8-8421-57da369f24cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-648-10ML - Milliliter36800-648733d32be-95aa-4c52-b3c8-540ce72ece7312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-64836800-648-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
ndc (package): 36800-648-10
ndc (product): 36800-648
ndc11 (package): 36800064810
spl id: 7d5fce56-1a65-4e69-afda-9123589511de
spl set id: 99bc8829-167b-4cf8-8421-57da369f24cd

Reported adverse events (FAERS/openFDA)#

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