FDA.reportPublic FDA data

NDC 81077-010-01 - SOLEP PREMIER HI GRO

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
81077-010
Requested NDC
81077-010-01
Package NDCs from labels
81077-010-01, 81077-010-02
Manufacturer
Kobizstar Co., Ltd. | Ester Co., Ltd.
Effective date
2020-11-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOLEP PREMIER HI GRO - Kobizstar Co., Ltd. | Ester Co., Ltd.Kobizstar Co., Ltd. | Ester Co., Ltd.2020-11-17HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81077-010-022025-01-30C16284748780-12cef2736-b6c9-d83d-e063-dadaa90ab31f5ae01fd8-8a20-4c24-8d8d-4de491a72f80

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-010-01SOLEP PREMIER HI GRO300 mL in 1 BOTTLESHAMPOO3001
81077-010-02SOLEP PREMIER HI GRO1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-010SOLEP PREMIER HI GRO (PANTHENOL, ZINC PYRITHIONE, SALICYLIC ACID) SHAMPOO [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_5ae01fd8-8a20-4c24-8d8d-4de491a72f80.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 90 of 97 · 1,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
111MedCo Medicated Bar 2 Pyrithione ZincPYRITHIONE ZINC111MedCo LLC22e0c6f9-8884-4869-b13f-fc4976da58da2023-11-20WarningsExact identifier
unii: R953O2RHZ5
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
unii: O414PZ4LPZ
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
unii: O414PZ4LPZ
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
unii: O414PZ4LPZ
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
unii: O414PZ4LPZ
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
unii: O414PZ4LPZ
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
unii: O414PZ4LPZ
Salicylicum acidumSALICYLIC ACIDBoiron86c07163-ba09-1bc8-e053-2991aa0a4caf2023-11-14Exact identifier
unii: O414PZ4LPZ
Salicylicum acidumSALICYLIC ACIDBoiron876077ae-aff7-e649-e053-2995a90a34cb2023-11-14Exact identifier
unii: O414PZ4LPZ
SIGNATURE CARE ACNE TREATMENTSALICYLIC ACIDSAFEWAY, INC.a60134d0-f788-90e8-e053-2a95a90acbde2023-11-14WarningsExact identifier
unii: O414PZ4LPZ
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
unii: O414PZ4LPZ
Aloe Coal 01PYRITHIONE ZINCT. SPRUILL, LLC40a94657-6722-46b1-87ed-a15bf60ffc7a2023-11-11WarningsExact identifier
unii: R953O2RHZ5
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
unii: O414PZ4LPZ
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
unii: O414PZ4LPZ
WARTRIN Wart RemoverSALICYLIC ACIDBALBOA COMPANIES LLC62c99f48-3dc1-4b41-8bc4-e93e2decadd92023-11-11WarningsExact identifier
unii: O414PZ4LPZ
HAIRCARE Physicians RecommendedSALICYLIC ACIDLAWRENCE E SAMUELS MD INC095fcc1c-8f5b-47bd-a32a-7f5da5d162cd2023-11-11WarningsExact identifier
unii: O414PZ4LPZ
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
unii: O414PZ4LPZ
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
unii: O414PZ4LPZ
Home Health Psoriasis Medicated Scalp and Body WashSALICYLIC ACIDHome Healthd10dad0e-34e1-49d4-a17a-36dbdbd66eb62023-11-06WarningsExact identifier
unii: O414PZ4LPZ
UFORIC Wart RemoverSALICYLIC ACIDUFORIC HEALTH LLC0d06cac6-5296-4d8a-b59e-966baac6be5f2023-11-06WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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