Phylorinol

Manufacturer: Schaffer Laboratories
Effective date: 2014-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 22:38:50

Label at a glance#

ProductPhylorinol

Active ingredientPHENOL

Label structure8 sections

Label contents#

Full prescribing information#

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient

Phenol 0.6%...............Oral Pain Reliever

Uses

temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

severe or persists more than 2 days
accompanied by :
rash
swelling
fever
headache
nausea
vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

sore mouth symptoms do not improve in 7 days.
irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.
Children under 6 years of age: consult a dentist or doctor

Other information

store at 15^o-30^oC (59^o-86^oF)

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Label

OTC - PURPOSE SECTION

Uses

temporary relief of occasional minor irritation, pain, sore mouth, and sore throat.

Label

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reech of children.

If more than what remains in mouth after spitting out is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Label

INDICATIONS & USAGE SECTION

Other information

store at 15^o-30^oC (59^o-86^oF)

Label

WARNINGS SECTION

Warnings

If used for sore throat:

Consult a doctor promplty if sore throat is

severe or persists more than 2 daysaccompanied by :
rash
swelling
fever
headache
nausea
vomiting

Unless directed by a doctor do not administer to children under 3 years of age.

If used for sore mouth:

See your dentist or doctor promptly if

sore mouth symptoms do not improve in 7 days.
irritation, pain, or redness persists or worsens

Stop use and ask a doctor if persistent or severe inflammatino occurs, which may indicate Iodine or Phenol sensitivity.

Label

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: gargle or swish around the mouth for at least 15 seconds and then spit out. Use every 2 hours or as directed by a dentis or doctor.
Children 6 to under 12 years of age: apply 10 milliliters to the affected area, gargle or swish around the mouth for at least 15 seconds then spit out. Use every 2 hours or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product.Children under 6 years of age: consult a dentist or doctor
Children under 6 years of age: consult a dentist or doctor

Label

INACTIVE INGREDIENT SECTION

Inactive ingredients

boric acid, carrageenan, chlorophyllin copper complex sodium, methyl salicylate, purified water, sodium chloride, sorbitol, strong iodine solution.

Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54061-101-01	2019-11-27	C162847	48780-1	9855e2a2-3efd-60a7-e053-dbdaa90a05bd	f643f019-4fdf-4bca-a5f1-7e8b4e171572

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54061-101-01	Phylorinol	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54061-101	PHYLORINOL LIQUID [SCHAFFER LABORATORIES]	7	Legacy NDC, 1 package rows	20140326_f643f019-4fdf-4bca-a5f1-7e8b4e171572.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PHENOL	ACTIVE INGREDIENT	339NCG44TV	7
PHENOL	ACTIVE MOIETY	339NCG44TV	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	7

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Phylorinol
PHENOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54061-101	54061-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENOL	339NCG44TV	ACTIB
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6ee89110-ae7c-4814-a8f7-5cafa703741f			f643f019-4fdf-4bca-a5f1-7e8b4e171572	2014-03-25	Warnings	Exact identifier spl id: 6ee89110-ae7c-4814-a8f7-5cafa703741f spl set id: f643f019-4fdf-4bca-a5f1-7e8b4e171572

Reported adverse events (FAERS/openFDA)#

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