FDA.reportPublic FDA data

Antibacterial free gel

Product NDC
78370-101
Requested package NDC
78370-101-15
11-digit product format
783700101
Labeler code
78370
Product ID
78370-101_a679a79b-2b82-09c1-e053-2995a90a50b9
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Xin Qi Cosmetics Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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 packagepackage78370-10178370-101-15IInactivated 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 · 19 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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
78370-101-01Antibacterial free gel
78370-101-02Antibacterial free gel
78370-101-03Antibacterial free gel
78370-101-04Antibacterial free gel
78370-101-05Antibacterial free gel
78370-101-06Antibacterial free gel
78370-101-07Antibacterial free gel
78370-101-08Antibacterial free gel
78370-101-09Antibacterial free gel
78370-101-10Antibacterial free gel
78370-101-11Antibacterial free gel
78370-101-12Antibacterial free gel
78370-101-13Antibacterial free gel
78370-101-14Antibacterial free gel
78370-101-15Antibacterial free gel
78370-101-16Antibacterial free gel
78370-101-17Antibacterial free gel
78370-101-18Antibacterial free gel
78370-101-19Antibacterial free gel
78370-101-20Antibacterial free gel
78370-101-21Antibacterial free gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78370-101-01Antibacterial free gel60 mL in 1 BOTTLELIQUID601
78370-101-02Antibacterial free gel80 mL in 1 BOTTLELIQUID801
78370-101-03Antibacterial free gel100 mL in 1 BOTTLELIQUID1001
78370-101-04Antibacterial free gel200 mL in 1 BOTTLELIQUID2001
78370-101-05Antibacterial free gel250 mL in 1 BOTTLELIQUID2501
78370-101-06Antibacterial free gel300 mL in 1 BOTTLELIQUID3001
78370-101-07Antibacterial free gel500 mL in 1 BOTTLELIQUID5001
78370-101-08Antibacterial free gel1000 mL in 1 BOTTLELIQUID10001
78370-101-09Antibacterial free gel5000 mL in 1 BOTTLELIQUID50001
78370-101-10Antibacterial free gel10000 mL in 1 BOTTLELIQUID100001
78370-101-11Antibacterial free gel4000 mL in 1 BOTTLELIQUID40001
78370-101-12Antibacterial free gel2000 mL in 1 BOTTLELIQUID20001
78370-101-13Antibacterial free gel1500 mL in 1 BOTTLELIQUID15001
78370-101-14Antibacterial free gel236 mL in 1 BOTTLELIQUID2361
78370-101-15Antibacterial free gel240 mL in 1 BOTTLELIQUID2401
78370-101-16Antibacterial free gel30 mL in 1 BOTTLELIQUID301
78370-101-17Antibacterial free gel3800 mL in 1 BOTTLELIQUID38001
78370-101-18Antibacterial free gel5 mL in 1 BOTTLELIQUID51
78370-101-19Antibacterial free gel8 mL in 1 BOTTLELIQUID81
78370-101-20Antibacterial free gel50 mL in 1 BOTTLELIQUID501
78370-101-21Antibacterial free gel3 mL in 1 BOTTLELIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78370-101ANTIBACTERIAL FREE GEL (ALCOHOL) LIQUID [GUANGZHOU XIN QI COSMETICS CO., LTD.]1Legacy NDC, 21 package rows20200526_a679b333-c083-c796-e053-2a95a90aba80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa679b333-c083-c796-e053-2a95a90aba801
1305100ethanol 0.75 ML/ML Topical GelSCDa679b333-c083-c796-e053-2a95a90aba801
1305100ethanol 75 % Topical GelSYa679b333-c083-c796-e053-2a95a90aba801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78370-101-1578370010115240 mL in 1 BOTTLE (78370-101-15) 240 ml2020-03-300000-00-00NoNoCurrent