FDA.reportPublic FDA data

BioShell

Manufacturer
BioFilm, Inc.
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:25

Label at a glance#

ProductBioShell
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

First aid to help prevent infection in minor oral irritations

Dosage and administration

Adults and children 12 years of age and older: spray into mouth where irritation is present 1 to 3 times, or spray and swish the liquid to affected areas. Expectorate any residual liquid. Use up to 3 times a day, or as directed by a dentist or doctor. Children under 12 years of age: consult a dentist or physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetylpridinium Chloride 0.1% -- Oral Antiseptic

Purpose

OTC - PURPOSE SECTION

Oral Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor oral irritations

Warnings

WARNINGS SECTION

  • Discontinue use and see your dentist or doctor promptly if sore mouth symptoms do not improve in 7 days, if irritation pain, or redness persists or worsens, or if swelling, rash, or fever develops.
  • Do not use children under 12 years of age
  • Keep out of reach of children
  • If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: spray into mouth where irritation is present 1 to 3 times, or spray and swish the liquid to affected areas. Expectorate any residual liquid. Use up to 3 times a day, or as directed by a dentist or doctor.
  • Children under 12 years of age: consult a dentist or physician.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Contol Center right away.

Other Information

OTHER SAFETY INFORMATION

Store between 15C and 30C (59F to 86F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, Glycerin, Xylitol, PEG-60 Hydrogenated Castor Oil, PVP-VA S-630 Copolymer, Sodium Benzonate USP/NF/FCC, Potassium Sorbate NF, Xanthan Gum, Sodium Saccharin, Berry Flavor.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-848-5900

BioShell

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioShell.jpgBioShell.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2596643cetylpyridinium chloride 0.1 % Mucosal SprayPSN2
2596643cetylpyridinium chloride 1 MG/ML Mucosal SpraySCD2
2596643cetylpyridinium chloride 0.1 % Mucosal SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66357-120-022022-07-29C16284748780-1e4f33bdf-afc5-d8a0-e053-dadaa90a6e4eBioShell

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66357-120-01BioShell30 mL in 1 BOTTLE, SPRAYSPRAY302
66357-120-02BioShell1 in 1 BOXSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66357-120BIOSHELL (CETYLPRIDINIUM CHLORIDE) SPRAY [BIOFILM, INC.]2Legacy NDC, 2 package rows20220502_da755149-dd67-5c87-e053-2995a90a1e77.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66357-12066357-120-01, 66357-120-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
da755149-dd64-5c87-e053-2995a90a1e77da755149-dd67-5c87-e053-2995a90a1e772022-03-17WarningsExact identifier
spl id: da755149-dd64-5c87-e053-2995a90a1e77
spl set id: da755149-dd67-5c87-e053-2995a90a1e77

Reported adverse events (FAERS/openFDA)#

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