SOLEP PREMIER HI GRO AMPOULE PACK

Product NDC
81077-030
Requested package NDC
81077-030-02
11-digit product format
810770030
Labeler code
81077
Product ID
81077-030_5d6f5f27-8b9a-4a20-8cb3-a934f005a397
Type
HUMAN OTC DRUG
Nonproprietary name
Panthenol, Menthol, Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Kobizstar Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
Marketing end
0000-00-00
Substance
PANTHENOL; MENTHOL; SALICYLIC ACID
Active strength
0 g/40mL; g/40mL; g/40mL
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 packagepackage81077-03081077-030-02IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81077-030-022025-01-30C16284748780-12cef2736-6f40-d83d-e063-dadaa90ab31f0a27152e-1118-43ea-a3a3-3a0e1b9bae2d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-030-01SOLEP PREMIER HI GRO AMPOULE PACK40 mL in 1 TUBELIQUID401
81077-030-02SOLEP PREMIER HI GRO AMPOULE PACK1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-030SOLEP PREMIER HI GRO AMPOULE PACK (PANTHENOL, MENTHOL, SALICYLIC ACID) LIQUID [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_0a27152e-1118-43ea-a3a3-3a0e1b9bae2d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81077-030-02810770030021 TUBE in 1 CARTON (81077-030-02) > 40 mL in 1 TUBE (81077-030-01) 1 tube2020-11-010000-00-00NoNoCurrent