FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
34839-003
11-digit product format
348390003
Labeler code
34839
Product ID
34839-003_a617da69-d54a-e1d9-e053-2995a90a354f
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Round Bridge Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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
34839-003-012021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-022021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-032021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer
34839-003-042021-07-23C16284748780-1c7ccaba7-1446-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34839-003-01Hand Sanitizer59 mL in 1 BOTTLEGEL592
34839-003-02Hand Sanitizer118 mL in 1 BOTTLEGEL1182
34839-003-03Hand Sanitizer236 mL in 1 BOTTLEGEL2362
34839-003-04Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34839-003HAND SANITIZER (ETHYL ALCOHOL) GEL [ROUND BRIDGE INC]2Legacy NDC, 4 package rows20200521_a5b4a83a-43e1-4ce8-e053-2995a90a0dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa5b4a83a-43e1-4ce8-e053-2995a90a0dac2
1305100ethanol 0.75 ML/ML Topical GelSCDa5b4a83a-43e1-4ce8-e053-2995a90a0dac2
1305100ethanol 75 % Topical GelSYa5b4a83a-43e1-4ce8-e053-2995a90a0dac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34839-003-013483900030159 mL in 1 BOTTLE (34839-003-01) 59 ml2020-05-160000-00-00NoNoCurrent
34839-003-0234839000302118 mL in 1 BOTTLE (34839-003-02) 118 ml2020-05-160000-00-00NoNoCurrent
34839-003-0334839000303236 mL in 1 BOTTLE (34839-003-03) 236 ml2020-05-160000-00-00NoNoCurrent
34839-003-0434839000304500 mL in 1 BOTTLE (34839-003-04) 500 ml2020-05-160000-00-00NoNoCurrent