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 80 of 98 · 1,945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.6e7524d7-b280-485a-815e-8af078e8acda2024-10-09WarningsExact identifier
unii: R953O2RHZ5
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.5d501ba0-a6f9-4f0d-86d5-0e8d9302737f2024-10-09WarningsExact identifier
unii: R953O2RHZ5
As I Am Dry and Itchy Scalp CarePYRITHIONE ZINCSalon Commodities, Inc.71ea4820-4160-41c2-e053-2a95a90a127d2024-10-09WarningsExact identifier
unii: R953O2RHZ5
As I Am Dry and Itchy Scalp Care Co WashPYRITHIONE ZINCSalon Commodities, Inc.71edee79-87ed-ff7c-e053-2995a90ae1302024-10-09WarningsExact identifier
unii: R953O2RHZ5
ClearSynergySALICYLIC ACIDSRL Enterprises, LLCb0ad3d4c-7afa-4503-b5d6-c88bf898155e2024-10-08WarningsExact identifier
unii: O414PZ4LPZ
Asepxia Acne TreatmentSALICYLIC ACIDGenomma Lab USA910d4320-bf89-436a-a8d4-54d001281dee2024-10-08WarningsExact identifier
unii: O414PZ4LPZ
Asepxia AcneSALICYLIC ACIDGenomma Lab USA9e8de726-480c-44c7-82c8-ce66412d881e2024-10-07WarningsExact identifier
unii: O414PZ4LPZ
Vanicream Z-BarPYRITHIONE ZINCPharmaceutical Specialties, Inc.21c84000-5d08-ae53-e063-6294a90a23622024-10-03WarningsExact identifier
unii: R953O2RHZ5
Atrix Clarifying TonerSALICYLIC ACIDPureTek Corporation191a2f96-eb97-4b45-b6a8-0d5835e7e7572024-10-02WarningsExact identifier
unii: O414PZ4LPZ
Head and Shoulders Classic Clean DandruffPYRITHIONE ZINCNavajo Manufacturing Company Inc3886d51a-b946-4862-a237-e8232df956372024-10-02WarningsExact identifier
unii: R953O2RHZ5
CornStickSALICYLIC ACIDBalassa Laboratories Inc.c453b06e-f9b0-4099-949a-6f5d2a8577e82024-10-01WarningsExact identifier
unii: O414PZ4LPZ
ZO Skin Health Retinol Plus Acne ComplexSALICYLIC ACIDZO Skin Health, Inc.1d65e4d2-0856-9135-e063-6294a90a5c662024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Atrix Acne TreatmentSALICYLIC ACIDPureTek Corporationba106b20-32aa-df90-e053-2995a90adaef2024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Atrix Antibacterial WashSALICYLIC ACIDPURETEK CORPORATIONbd5b6f29-5b97-0853-e053-2a95a90aed592024-10-01WarningsExact identifier
unii: O414PZ4LPZ
WartStick PlantarSALICYLIC ACIDBalassa Laboratories Inc.dfe2aa35-d780-4ae8-b230-019ec2e1a5c72024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Target Up and Up Salicylic Acid Acne WashSALICYLIC ACIDTARGET CORPORATION235aa04e-746f-d66a-e063-6394a90a11442024-09-30WarningsExact identifier
unii: O414PZ4LPZ
Target Up and Up Moisturizer with Salicylic Acid Acne TreatmentSALICYLIC ACIDTARGET CORPORATION235ca067-e2d4-ca01-e063-6394a90a10502024-09-30WarningsExact identifier
unii: O414PZ4LPZ
CVS Daily Dandruff Anti-dandruffPYRITHIONE ZINCCVS Health705f5ced-a245-42c8-a32f-baaddaa11c6e2024-09-27WarningsExact identifier
unii: R953O2RHZ5
Acne Phage SerumENCAPSULATED SALICYLIC ACIDAllure Labs230d173f-92c1-2e98-e063-6394a90acb212024-09-26WarningsExact identifier
unii: O414PZ4LPZ
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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