FDA.reportPublic FDA data

TERRA PURE Spa Collection Fresh Aloe Hand Sanitizer Paraben and Gluten Free

Product NDC
77573-003
Requested package NDC
77573-003-01
11-digit product format
775730003
Labeler code
77573
Product ID
77573-003_adce7f69-38c1-dd04-e053-2995a90a1c04
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Jiangsu Aimeili Cosmetic Co.,Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-25
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage77573-00377573-003-01IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage77573-00377573-003-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage77573-00377573-003-01IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage77573-00377573-003-01IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77573-003-012024-01-05C16284748780-1d6a99b39-609a-a426-e053-dadaa90af4c277573-003
77573-003-012022-01-28C16284748780-1d6a99b39-609a-a426-e053-dadaa90af4c277573-003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77573-003-01TERRA PURE Spa Collection Fresh Aloe Hand Sanitizer Paraben and Gluten Free3785 mL in 1 BOTTLESOLUTION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77573-003TERRA PURE SPA COLLECTION FRESH ALOE HAND SANITIZER PARABEN AND GLUTEN FREE (ALCOHOL) SOLUTION [JIANGSU AIMEILI COSMETIC CO.,LTD.]2Legacy NDC, 1 package rows20240105_e5f88f94-a9eb-4db8-92d9-eb6a93ab0a93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSNe5f88f94-a9eb-4db8-92d9-eb6a93ab0a932
582753ethanol 0.7 ML/ML Topical SolutionSCDe5f88f94-a9eb-4db8-92d9-eb6a93ab0a932
582753ethanol 70 % Topical SolutionSYe5f88f94-a9eb-4db8-92d9-eb6a93ab0a932
582753ethyl alcohol 70 % Topical SolutionSYe5f88f94-a9eb-4db8-92d9-eb6a93ab0a932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77573-003-01775730003013785 mL in 1 BOTTLE (77573-003-01) 3785 ml2020-08-250000-00-00NoNoCurrent