FDA.reportPublic FDA data

SaniGuard-SF

Product NDC
58575-150
Requested package NDC
58575-150-42
11-digit product format
585750150
Labeler code
58575
Product ID
58575-150_e2ae02d1-6f7e-4192-e053-2a95a90aa3be
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Inopak. Ltd
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-05-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58575-15058575-150-42IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
58575-150-01Inopak SaniGuard-SF
58575-150-02Inopak SaniGuard-SF
58575-150-03Inopak SaniGuard-SF
58575-150-10Inopak SaniGuard-SF
58575-150-12Inopak SaniGuard-SF
58575-150-18Inopak SaniGuard-SF
58575-150-37Inopak SaniGuard-SF
58575-150-42Inopak SaniGuard-SF
58575-150-80Inopak SaniGuard-SF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58575-150-01SaniGuard-SF1000 mL in 1 POUCHLIQUID10006
58575-150-02SaniGuard-SF60 mL in 1 BOTTLELIQUID606
58575-150-03SaniGuard-SF50 mL in 1 BOTTLELIQUID506
58575-150-10SaniGuard-SF1000 mL in 1 BAGLIQUID10006
58575-150-12SaniGuard-SF1250 mL in 1 BAGLIQUID12506
58575-150-18SaniGuard-SF540 mL in 1 BOTTLELIQUID5406
58575-150-37SaniGuard-SF3840 mL in 1 BAGLIQUID38406
58575-150-42SaniGuard-SF3800 mL in 1 BOTTLELIQUID38006
58575-150-80SaniGuard-SF800 mL in 1 BOTTLELIQUID8006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
ALCOHOLACTIVE MOIETY3K9958V90MSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8ESANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
POLYETHYLENE GLYCOL 600000INACTIVE INGREDIENT2126FD486LSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
POLYQUATERNIUM-10 (30000 MPA.S AT 2%)INACTIVE INGREDIENTC7RDC8Y4JSSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RSANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58575-150SANIGUARD-SF (ALCOHOL) LIQUID [INOPAK. LTD]6Legacy NDC, 9 package rows20220702_f05b8a05-1eb8-4734-90e0-9948e685854c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616805ethanol 70 % Topical FoamPSNf05b8a05-1eb8-4734-90e0-9948e685854c6
616805ethanol 0.7 ML/ML Topical FoamSCDf05b8a05-1eb8-4734-90e0-9948e685854c6
616805ethanol 70 % Topical FoamSYf05b8a05-1eb8-4734-90e0-9948e685854c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58575-150-42585750150423800 mL in 1 BOTTLE (58575-150-42) 3800 ml2021-04-200000-00-00NoNoCurrent