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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa920f62-352c-4c67-9575-e78f12edef84Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monarch Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa920f62-352c-4c67-9575-e78f12edef842023-10-26WarningsExact identifier
ndc (product): 63710-005

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