FDA.reportPublic FDA data

Guardian Angel

Product NDC
80113-316
11-digit product format
801130316
Labeler code
80113
Product ID
80113-316_acf92dbd-9402-2a2c-e053-2995a90abce3
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorine Dioxide (CIO2) Water
Dosage form
LIQUID
Route
TOPICAL
Labeler
BTC TOP, INC
Application
part349
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-25
Marketing end
0000-00-00
Substance
CHLORINE DIOXIDE; WATER
Active strength
5 mg/1; L/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80113-316IInactivated by FDA2026-07-31
excluded packagepackage80113-31680113-316-01IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80113-316-012022-01-28C16284748780-1d6a99b39-e148-a426-e053-dadaa90af4c2acf92dbd-9401-2a2c-e053-2995a90abce3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80113-316-01Guardian Angel1 in 1 BOTTLELIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80113-316GUARDIAN ANGEL (CHLORINE DIOXIDE (CIO2) WATER) LIQUID [BTC TOP, INC]1Legacy NDC, 1 package rows20200827_acf92dbd-9401-2a2c-e053-2995a90abce3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80113-316-01801130316011 LIQUID in 1 BOTTLE (80113-316-01) 1 liquid2020-08-250000-00-00NoNoCurrent