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 96 of 97 · 1,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
unii: O414PZ4LPZ
ZolidynePYRITHIONE ZINCTopiderm, Inc.6d5eaecc-a3a1-4739-ae5b-66df4a15cd212019-11-20WarningsExact identifier
unii: R953O2RHZ5
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
unii: O414PZ4LPZ
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
unii: O414PZ4LPZ
Tinnitus ReliefCINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.Homeocare Laboratories30d67273-b9ec-4f3e-ace6-87a68325aaf12019-02-28WarningsExact identifier
unii: O414PZ4LPZ
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
NAS MAX STRENGTH SPOT TREATMENTSALICYLIC ACIDBURT'S BEES, INC.316a2d5e-4c7e-4b61-e054-00144ff88e882018-12-03WarningsExact identifier
unii: O414PZ4LPZ
Cover FX Mattifying Primer Plus Acne TreatmentSALICYLIC ACIDCover FX Skin Care Inc7bcf8a39-9c98-13bc-e053-2991aa0a3beb2018-11-29WarningsExact identifier
unii: O414PZ4LPZ
Acne Advanced CleansingSALICYLIC ACIDEminence Organic Skin Care Ltd.75ad5eab-8035-41c5-b6b1-ad85fa26fc3a2018-11-14WarningsExact identifier
unii: O414PZ4LPZ
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Salicylic AcidSALICYLIC ACIDD3 Development, Inc.6b650f3d-a242-7a30-e053-2991aa0a777e2018-05-04WarningsExact identifier
unii: O414PZ4LPZ
Well at Walgreens Blemish and Blackhead Control ApricotSALICYLIC ACIDWalgreen Company17a4de6f-3fb4-40e7-9edc-fbbf2edca0222018-04-18WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidSALICYLIC ACIDKMM Pharmaceuticals, LLC17b570e7-3cf8-2f20-e054-00144ff8d46c2017-12-18Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Overnight ClearingSALICYLIC ACIDDermalogica, Inc.6f6d9bd9-a1c8-4f8c-b7b8-fe9748a06c2c2017-12-04WarningsExact identifier
unii: O414PZ4LPZ
Acne Cleanser W/ Salicylic AcidSALICYLIC ACIDAllure Labs, Inc6f831f09-03c2-49a4-b677-6260057771262017-12-01WarningsExact identifier
unii: O414PZ4LPZ
SALICYLIC ACIDSALICYLIC ACIDKMM Pharmaceuticals, LLC5df4c5b6-3ad2-7f2c-e053-2991aa0a021b2017-11-14Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: O414PZ4LPZ
XALIXSALICYLIC ACIDKMM Pharmaceuticals, LLC5c60df47-58cf-5226-e053-2a91aa0a16462017-10-25Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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