FDA.reportPublic FDA data

C-tizers 99.9

Product NDC
80637-001
Requested package NDC
80637-001-10
11-digit product format
806370001
Labeler code
80637
Product ID
80637-001_9aac9183-b038-423b-985f-c4df479e40e7
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol, Isopropyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
TIZER KOZMETIK LIMITED SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-06
Marketing end
0000-00-00
Substance
ALCOHOL; ISOPROPYL ALCOHOL
Active strength
60 mL/100mL; 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 packagepackage80637-00180637-001-10IInactivated by FDA2026-10-12

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
80637-001-01bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-02bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-03bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-04bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-05bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-06bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-07bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-08bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-09bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-10bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-11bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c
80637-001-12bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80637-001-01C-tizers 99.91.5 mL in 1 POUCHGEL1.52
80637-001-02C-tizers 99.91.5 mL in 1 PACKETGEL1.52
80637-001-03C-tizers 99.93 mL in 1 POUCHGEL32
80637-001-04C-tizers 99.93 mL in 1 PACKETGEL32
80637-001-05C-tizers 99.950 mL in 1 BOTTLEGEL502
80637-001-06C-tizers 99.9100 mL in 1 BOTTLEGEL1002
80637-001-07C-tizers 99.9250 mL in 1 BOTTLEGEL2502
80637-001-08C-tizers 99.9500 mL in 1 BOTTLEGEL5002
80637-001-09C-tizers 99.91000 mL in 1 BOTTLEGEL10002
80637-001-10C-tizers 99.95000 mL in 1 BOTTLEGEL50002
80637-001-11C-tizers 99.9150000 mL in 1 DRUMGEL1500002
80637-001-12C-tizers 99.945 mL in 1 POUCHGEL452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80637-001C-TIZERS 99.9 (ETHYL ALCOHOL, ISOPROPYL ALCOHOL) GEL [TIZER KOZMETIK LIMITED SIRKETI]2Legacy NDC, 12 package rows20201212_bf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2381736ethanol 60 % / isopropyl alcohol 10 % Topical GelPSNbf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c2
2381736ethanol 0.6 ML/ML / isopropyl alcohol 0.1 ML/ML Topical GelSCDbf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c2
2381736ethanol 60 % / isopropyl alcohol 10 % Topical GelSYbf7bbabb-66ac-49c0-8cfa-61c3e20c1b7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80637-001-10806370001105000 mL in 1 BOTTLE (80637-001-10) 5000 ml2020-10-060000-00-00NoNoCurrent