FDA.reportPublic FDA data

AT-MOSPHERE

Product NDC
77598-129
Requested package NDC
77598-129-05
11-digit product format
775980129
Labeler code
77598
Product ID
77598-129_ab875d99-e491-c078-e053-2a95a90a1c9f
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Ouzhuang Biological Technology Co Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-15
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

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 packagepackage77598-12977598-129-05IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
77598-129-01Guangzhou @MOSPHERE Gel
77598-129-02Guangzhou @MOSPHERE Gel
77598-129-03Guangzhou @MOSPHERE Gel
77598-129-04Guangzhou @MOSPHERE Gel
77598-129-05Guangzhou @MOSPHERE Gel
77598-129-06Guangzhou @MOSPHERE Gel
77598-129-07Guangzhou @MOSPHERE Gel
77598-129-08Guangzhou @MOSPHERE Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77598-129-01AT-MOSPHERE30 mL in 1 BOTTLEGEL302
77598-129-02AT-MOSPHERE60 mL in 1 BOTTLEGEL602
77598-129-03AT-MOSPHERE100 mL in 1 BOTTLEGEL1002
77598-129-04AT-MOSPHERE300 mL in 1 BOTTLEGEL3002
77598-129-05AT-MOSPHERE500 mL in 1 BOTTLEGEL5002
77598-129-06AT-MOSPHERE1000 mL in 1 BOTTLEGEL10002
77598-129-07AT-MOSPHERE3800 mL in 1 BOTTLEGEL38002
77598-129-08AT-MOSPHERE5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77598-129AT-MOSPHERE (SANITIZING GEL) GEL [GUANGZHOU OUZHUANG BIOLOGICAL TECHNOLOGY CO LTD]2Legacy NDC, 8 package rows20200729_ab85eae3-a014-056e-e053-2a95a90a0590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNab85eae3-a014-056e-e053-2a95a90a05902
1305100ethanol 0.75 ML/ML Topical GelSCDab85eae3-a014-056e-e053-2a95a90a05902
1305100ethanol 75 % Topical GelSYab85eae3-a014-056e-e053-2a95a90a05902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77598-129-0577598012905500 mL in 1 BOTTLE (77598-129-05) 500 ml2020-05-150000-00-00NoNoCurrent