FDA.reportPublic FDA data

NDC 81077-020-01 - SOLEP PREMIER HI GRO TONIC

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
81077-020
Requested NDC
81077-020-01
Package NDCs from labels
81077-020-01, 81077-020-02
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 TONIC - 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
81077-020-022025-01-30C16284748780-12cef2736-7066-d83d-e063-dadaa90ab31fbe18abc9-df84-4455-a26e-470841af30c6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-020-01SOLEP PREMIER HI GRO TONIC100 mL in 1 BOTTLE, SPRAYSPRAY1001
81077-020-02SOLEP PREMIER HI GRO TONIC1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-020SOLEP PREMIER HI GRO TONIC (MENTHOL, PANTHENOL, SALICYLIC ACID) SPRAY [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_be18abc9-df84-4455-a26e-470841af30c6.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 325 · 6,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Advanced Hand SanitizerALCOHOLWakefern Food Corp.9859ef63-70a7-4986-ad22-0c1c7333c6cb2026-02-13WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerALCOHOLWakefern Food Corp.c441a053-d241-48b4-a33b-971b890f27402026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLWakefern Food Corp.c5dd2b25-9003-4c4b-8a86-ecf186695ce32026-02-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC0d97cb54-1b9c-4aff-a15c-3bf9b66782092026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
BCBG GENERATION HAND SANITIZER BERGAMOT SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOfaba4dec-67dc-4db0-a48b-e39b3edf2f992026-02-13WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA HEAVEN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.43c129d8-0ad3-4630-acd9-b604cbda36e02026-02-13WarningsExact identifier
unii: 3K9958V90M
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
unii: O414PZ4LPZ
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
unii: ZY81Z83H0X
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact identifier
unii: O414PZ4LPZ
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC2022986a-2a93-4291-887c-c23f2b2c83a72026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC4ad7818e-caee-49f0-81e8-bda6fbd64ea52026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Hand SanitizerALCOHOLWinCo Foods, LLC5f5ee353-2387-4b15-af39-5bbe3fda4dc42026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLCef20af6a-4547-4b63-8ffe-989112e3030f2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Advanced Hand SanitizerETHYL ALCOHOLWinco Foods25204aac-e940-45dc-804b-81fd141449d72026-02-12Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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