FDA.reportPublic FDA data

Assured Instant

Product NDC
58503-078
Requested package NDC
58503-078-02
11-digit product format
585030078
Labeler code
58503
Product ID
58503-078_9270d888-53d2-352f-e053-2a95a90ab3b8
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-03
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage58503-07858503-078-02IInactivated by FDA2026-10-05

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-078-022024-01-30C16284748780-11030e365-0193-111a-e063-dadaa90a10e2Assured Instant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-078-01Assured Instant237 mL in 1 PACKAGEGEL2372
58503-078-02Assured Instant3 in 1 PACKAGEGEL32

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ALCOHOLACTIVE MOIETY3K9958V90MASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-078ASSURED INSTANT (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2Legacy NDC, 2 package rows20190914_5d16aea2-4697-49d8-9bbb-4a4836df464b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN5d16aea2-4697-49d8-9bbb-4a4836df464b2
581660ethanol 0.62 ML/ML Topical GelSCD5d16aea2-4697-49d8-9bbb-4a4836df464b2
581660ethanol 62 % Topical GelSY5d16aea2-4697-49d8-9bbb-4a4836df464b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-078-02585030078023 PACKAGE in 1 PACKAGE (58503-078-02) > 237 mL in 1 PACKAGE (58503-078-01) 3 package2015-06-030000-00-00NoNoCurrent