FDA.reportPublic FDA data

Wolke Hand Sanitizer

Product NDC
78207-000
Requested package NDC
78207-000-03
11-digit product format
782070000
Labeler code
78207
Product ID
78207-000_a8e9747f-036c-eb8c-e053-2a95a90a635d
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Hidro Soluciones Integrales, S.A. de C.V.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-25
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78207-00078207-000-03IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78207-000-012022-01-28C16284748780-1d6a99b39-8fa7-a426-e053-dadaa90af4c2Wolke Hand Sanitizer
78207-000-022022-01-28C16284748780-1d6a99b39-8fa7-a426-e053-dadaa90af4c2Wolke Hand Sanitizer
78207-000-032022-01-28C16284748780-1d6a99b39-8fa7-a426-e053-dadaa90af4c2Wolke Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78207-000-01Wolke Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78207-000-02Wolke Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78207-000-03Wolke Hand Sanitizer900 mL in 1 BOTTLEGEL9001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78207-000WOLKE HAND SANITIZER (ALCOHOL) GEL [HIDRO SOLUCIONES INTEGRALES, S.A. DE C.V.]1Legacy NDC, 3 package rows20200626_eebac2ae-cc44-471e-9830-da5a5a5a30fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNeebac2ae-cc44-471e-9830-da5a5a5a30fb1
581662ethanol 0.7 ML/ML Topical GelSCDeebac2ae-cc44-471e-9830-da5a5a5a30fb1
581662ethanol 70 % Topical GelSYeebac2ae-cc44-471e-9830-da5a5a5a30fb1
581662ethyl alcohol 70 % Topical GelSYeebac2ae-cc44-471e-9830-da5a5a5a30fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78207-000-0378207000003900 mL in 1 BOTTLE (78207-000-03) 900 ml2020-06-250000-00-00NoNoCurrent