FDA.reportPublic FDA data

SIMIKA

Product NDC
77598-133
11-digit product format
775980133
Labeler code
77598
Product ID
77598-133_ab87882a-48d2-3c0d-e053-2995a90a4423
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Ouzhuang Biological Technology Co Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-15
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77598-133-012022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-022022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-032022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-042022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-052022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-062022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-072022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-082022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-102022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel
77598-133-112022-01-28C16284748780-1d6a99b39-4450-a426-e053-dadaa90af4c2Guangzhou SIMIKA 75% Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77598-133-01SIMIKA30 mL in 1 BOTTLEGEL301
77598-133-02SIMIKA60 mL in 1 BOTTLEGEL601
77598-133-03SIMIKA100 mL in 1 BOTTLEGEL1001
77598-133-04SIMIKA300 mL in 1 BOTTLEGEL3001
77598-133-05SIMIKA500 mL in 1 BOTTLEGEL5001
77598-133-06SIMIKA1000 mL in 1 BOTTLEGEL10001
77598-133-07SIMIKA3800 mL in 1 BOTTLEGEL38001
77598-133-08SIMIKA5000 mL in 1 BOTTLEGEL50001
77598-133-10SIMIKA30 mL in 1 PACKETGEL301
77598-133-11SIMIKA10 mL in 1 PACKETGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77598-133SIMIKA (SANITIZING GEL) GEL [GUANGZHOU OUZHUANG BIOLOGICAL TECHNOLOGY CO LTD]1Legacy NDC, 10 package rows20200729_ab87882a-48d4-3c0d-e053-2995a90a4423.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNab87882a-48d4-3c0d-e053-2995a90a44231
1305100ethanol 0.75 ML/ML Topical GelSCDab87882a-48d4-3c0d-e053-2995a90a44231
1305100ethanol 75 % Topical GelSYab87882a-48d4-3c0d-e053-2995a90a44231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77598-133-017759801330130 mL in 1 BOTTLE (77598-133-01) 30 ml2020-05-150000-00-00NoNoCurrent
77598-133-027759801330260 mL in 1 BOTTLE (77598-133-02) 60 ml2020-05-150000-00-00NoNoCurrent
77598-133-0377598013303100 mL in 1 BOTTLE (77598-133-03) 100 ml2020-05-150000-00-00NoNoCurrent
77598-133-0477598013304300 mL in 1 BOTTLE (77598-133-04) 300 ml2020-05-150000-00-00NoNoCurrent
77598-133-0577598013305500 mL in 1 BOTTLE (77598-133-05) 500 ml2020-05-150000-00-00NoNoCurrent
77598-133-06775980133061000 mL in 1 BOTTLE (77598-133-06) 1000 ml2020-05-150000-00-00NoNoCurrent
77598-133-07775980133073800 mL in 1 BOTTLE (77598-133-07) 3800 ml2020-05-150000-00-00NoNoCurrent
77598-133-08775980133085000 mL in 1 BOTTLE (77598-133-08) 5000 ml2020-05-150000-00-00NoNoCurrent
77598-133-107759801331030 mL in 1 PACKET (77598-133-10) 30 ml2020-05-150000-00-00NoNoCurrent
77598-133-117759801331110 mL in 1 PACKET (77598-133-11) 10 ml2020-05-150000-00-00NoNoCurrent