FDA.reportPublic FDA data

NDC 66357-120-01 - BioShell

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
66357-120
Requested NDC
66357-120-01
Package NDCs from labels
66357-120-01, 66357-120-02
Manufacturer
BioFilm, Inc.
Effective date
2022-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BioShellBioFilm, Inc.2022-03-17HUMAN OTC DRUG LABEL

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

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 6 of 29 · 571 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX
HealthCETYLPYRIDINIUM CHLORIDEOld East Main Co.d870e73a-2f35-4fa1-861c-81bd63603d3b2026-03-02Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
unii: PDC6A3C0OX
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: PDC6A3C0OX
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEThe Kroger Co.922bff32-7536-4a6d-b04b-0b02f14fbecc2026-02-27Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEThe Kroger Co.0e61d4a1-0b81-4bca-bdb3-b9927278b7692026-02-27Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDEWalmart Inc.8916fb44-da82-41d5-941a-293ef1d67dd02026-02-27Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEMeijer, Inc.ea55487c-a13f-41bd-b952-a7d848480ffa2026-02-24Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDEMeijer, Inc.9b4aa3fb-989d-4abc-9418-b4ff249047bb2026-02-24Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
MintCETYLPYRIDINIUM CHLORIDEBetter Living Brands, LLC4af3b64e-060e-4c0f-a39b-f0bfb92dceb82026-02-23WarningsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDEPerrigo Direct, Inc4d452c85-8e28-4915-a638-c71fc9cc77d62026-02-19Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
MintCETYLPYRIDINIUM CHLORIDEMeijer, Inc.de72012b-c5f5-4883-865e-3bc8d075ef842026-02-19Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation51d2100a-bbd8-4937-aa2a-a49a1224f43b2026-02-18Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Equaline Multi-Action AntisepticCETYLPYRIDINIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI138d04b5-0b35-45f0-87a1-7a90cef2a9bc2026-02-17Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
ANTISEPTICCETYLPYRIDINIUM CHLORIDEValu Merchandisers Company34f1e92a-be34-4da1-84da-3e8a2a74693b2026-02-16Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
AntisepticCETYLPYRIDINIUM CHLORIDETopco Associates LLC857e8bc4-125f-4796-ac10-6880702816fe2026-02-13Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDETopco Associates LLCc20cbcca-1509-491b-9ec4-3d9611b311592026-02-13Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDETopco Associates LLC3fefe9b3-d61d-494d-bd85-5d2cf83213982026-02-13Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Mint Alcohol FreeCETYLPYRIDINIUM CHLORIDEWinCo Foods LLC30b50da5-14d0-d0c7-e063-6394a90a091b2026-02-12Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P

Reported adverse events (FAERS/openFDA)#

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