FDA.reportPublic FDA data

Pyroxy Liquid-80B

Product NDC
78517-801
Requested package NDC
78517-801-27
11-digit product format
785170801
Labeler code
78517
Product ID
78517-801_d6d2cf6d-08ad-ded1-e053-2995a90ab1ec
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL 80%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pyrock Chemical
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage78517-80178517-801-27IInactivated 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 · 15 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
78517-801-012024-01-30Pyroxy Liquid-80B - 80%
78517-801-272024-01-30Pyroxy Liquid-80B - 80%
78517-801-332024-01-30Pyroxy Liquid-80B - 80%
78517-801-552024-01-30Pyroxy Liquid-80B - 80%
78517-801-672024-01-30Pyroxy Liquid-80B - 80%
78517-801-912024-01-30Pyroxy Liquid-80B - 80%
78517-801-922024-01-30Pyroxy Liquid-80B - 80%
78517-801-952024-01-30Pyroxy Liquid-80B - 80%
78517-801-012022-01-30Pyroxy Liquid-80B - 80%
78517-801-272022-01-30Pyroxy Liquid-80B - 80%
78517-801-332022-01-30Pyroxy Liquid-80B - 80%
78517-801-552022-01-30Pyroxy Liquid-80B - 80%
78517-801-672022-01-30Pyroxy Liquid-80B - 80%
78517-801-912022-01-30Pyroxy Liquid-80B - 80%
78517-801-922022-01-30Pyroxy Liquid-80B - 80%
78517-801-952022-01-30Pyroxy Liquid-80B - 80%
78517-801-012022-01-28Pyroxy Liquid-80B - 80%
78517-801-272022-01-28Pyroxy Liquid-80B - 80%
78517-801-332022-01-28Pyroxy Liquid-80B - 80%
78517-801-552022-01-28Pyroxy Liquid-80B - 80%
78517-801-672022-01-28Pyroxy Liquid-80B - 80%
78517-801-912022-01-28Pyroxy Liquid-80B - 80%
78517-801-922022-01-28Pyroxy Liquid-80B - 80%
78517-801-952022-01-28Pyroxy Liquid-80B - 80%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78517-801-01Pyroxy Liquid-80B3785.41 mL in 1 BOTTLELIQUID3785.412
78517-801-27Pyroxy Liquid-80B1040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1040988.22
78517-801-33Pyroxy Liquid-80B1249185.9 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1249185.92
78517-801-55Pyroxy Liquid-80B208197.65 mL in 1 DRUMLIQUID208197.652
78517-801-67Pyroxy Liquid-80B25362259 mL in 1 TANKLIQUID253622592
78517-801-91Pyroxy Liquid-80B1000 mL in 1 BOTTLELIQUID10002
78517-801-92Pyroxy Liquid-80B250 mL in 1 BOTTLELIQUID2502
78517-801-95Pyroxy Liquid-80B18927.05 mL in 1 PAILLIQUID18927.052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78517-801PYROXY LIQUID-80B (ALCOHOL 80%) LIQUID [PYROCK CHEMICAL]2Legacy NDC, 8 package rows20220131_a7d0c766-c9d8-3457-e053-2995a90ab480.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNa7d0c766-c9d8-3457-e053-2995a90ab4802
1039339ethanol 0.8 ML/ML Topical SolutionSCDa7d0c766-c9d8-3457-e053-2995a90ab4802
1039339ethanol 80 % Topical SolutionSYa7d0c766-c9d8-3457-e053-2995a90ab4802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78517-801-27785170801271040988.2 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (78517-801-27) 1040988.2 ml2020-03-300000-00-00NoNoCurrent