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 5 of 29 · 571 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET UP AND UP GUM CARECETYLPYRIDINIUM CHLORIDE 0.05%Target Corporation2981529a-2bcd-3e9e-e063-6294a90a72362026-04-02WarningsExact identifier
unii: D9OM4SK49P
twice. Oral Wellness Gum ShieldCETYLPYRIDINIUM CHLORIDETwice Twice LLC3d48e2f6-99b6-e8bc-e063-6294a90a1afc2026-04-02WarningsExact identifier
unii: D9OM4SK49P
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
unii: D9OM4SK49P
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
unii: D9OM4SK49P
Redness ReliefGLYCERIN, NAPHAZOLINE HCLPharmadel LLC4c113bb9-814f-d92d-e063-6294a90a83022026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Brush Buddies Oral Rinse Clean MintCETYLPYRIDINIUM CHLORIDEAshtel Studios, Incf68cbc89-c3b2-4cfa-9b6e-346a73ac85442026-03-13WarningsExact identifier
unii: D9OM4SK49P
Cetylpyridinium ChlorideCETYLPYRIDINIUM CHLORIDEPublix Super Markets, Inc.4cc128d9-69ab-3f0b-e063-6294a90a6a742026-03-11Warnings, Adverse reactionsExact identifier
unii: D9OM4SK49P
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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