FDA.reportPublic FDA data

Monarch Hand Sanitizer

Product NDC
63710-005
11-digit product format
637100005
Labeler code
63710
Product ID
63710-005_08a17e39-fe9f-3976-e063-6294a90ae8ca
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Laboratorios Zeyco, S.A. de C.V.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-24
Substance
ALCOHOL
Active strength
.7 L/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monarch Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.7 L/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63710-005-01Monarch Hand Sanitizer0.5 L in 1 BOTTLE, PUMPGEL0.55
63710-005-02Monarch Hand Sanitizer3.7 L in 1 BOTTLE, PUMPGEL3.75
63710-005-03Monarch Hand Sanitizer1 L in 1 BOTTLE, PUMPGEL15
63710-005-04Monarch Hand Sanitizer0.06 L in 1 BOTTLE, PLASTICGEL0.065

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63710-005MONARCH HAND SANITIZER (ALCOHOL) GEL [LABORATORIOS ZEYCO, S.A. DE C.V.]5Current NDC, Legacy NDC, 4 package rows20231027_aa920f62-352c-4c67-9575-e78f12edef84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNaa920f62-352c-4c67-9575-e78f12edef845
581662ethanol 0.7 ML/ML Topical GelSCDaa920f62-352c-4c67-9575-e78f12edef845
581662ethanol 70 % Topical GelSYaa920f62-352c-4c67-9575-e78f12edef845
581662ethyl alcohol 70 % Topical GelSYaa920f62-352c-4c67-9575-e78f12edef845

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63710-005-0163710000501.5 L in 1 BOTTLE, PUMP (63710-005-01) 2020-09-240000-00-00NoNoCurrent
63710-005-02637100005023.7 L in 1 BOTTLE, PUMP (63710-005-02) 3.7 l2020-09-240000-00-00NoNoCurrent
63710-005-03637100005031 L in 1 BOTTLE, PUMP (63710-005-03) 1 l2020-09-240000-00-00NoNoCurrent
63710-005-0463710000504.06 L in 1 BOTTLE, PLASTIC (63710-005-04) 2020-10-070000-00-00NoNoCurrent