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 108 of 325 · 6,487 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsLIDOCAINE 4% AND MENTHOL 1% PATCHDr. Sabharwal's Wound Care10249d0f-5ee1-6892-e063-6394a90a967e2026-01-23WarningsExact identifier
unii: L7T10EIP3A
Smart Care WILD CHERRY BLOSSOM HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.944a5834-ece6-46e5-bc15-70b25b8103e12026-01-23WarningsExact identifier
unii: 3K9958V90M
EmuaidSALICYLIC ACIDSpeer Laboratories, LLCa1486276-30f7-4245-815b-d57edf411cda2026-01-23WarningsExact identifier
unii: O414PZ4LPZ
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
unii: L7T10EIP3A
Neutrogena Evenly Clear Acne CleanserSALICYLIC ACIDKenvue Brands LLC3e985a61-2aa7-963b-e063-6294a90a7c122026-01-22WarningsExact identifier
unii: O414PZ4LPZ
Easment DMSO creamMENTHOL 1.00%Easment LLC48f5544e-1cfd-864a-e063-6394a90a71f12026-01-22WarningsExact identifier
unii: L7T10EIP3A
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
unii: L7T10EIP3A
Resurfacing acne swipesSALICYLIC ACIDSKIN PS Brands9629fdcb-f3b5-9685-e053-2a95a90a02302026-01-22WarningsExact identifier
unii: O414PZ4LPZ
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
unii: O414PZ4LPZ
Covex Antibacterial Hand Sanitizer, COOL BREEZEALCOHOLDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a1587e-1ae1-d34b-e053-2995a90a2ce92026-01-22WarningsExact identifier
unii: 3K9958V90M
Covex Antibacterial Hand Sanitizer, FRESH ALOEALCOHOLDALAN KIMYA ENDUSTRI ANONIM SIRKETIa2a19dd5-57b2-6c98-e053-2a95a90a96cd2026-01-22WarningsExact identifier
unii: 3K9958V90M
X-Treme FreezeCOLD THERAPY GELDynarex Corporation79f0802f-03ad-bf8f-e053-2991aa0ae4b52026-01-22WarningsExact identifier
unii: L7T10EIP3A
DOP Ethyl Alcohol 70%ETHYL ALCOHOLOmega & Delta Co., Inc.b96d85f8-739c-4b96-9dd5-8119ebf66c9f2026-01-21WarningsExact identifier
unii: 3K9958V90M
Dermatouch Acnecare Facial ScrubSALICYLIC ACIDSpa de Soleil025d4242-9e7d-9ba1-e063-6294a90af7522026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare PadsSALICYLIC ACIDSpa de Soleil025d79e9-3aeb-40b9-e063-6394a90a48a42026-01-21WarningsExact identifier
unii: O414PZ4LPZ
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfcbe1-8e0c-1715-e063-6394a90a733f2026-01-21WarningsExact identifier
unii: 3K9958V90M
Dermatouch Acnecare MoisturizerSALICYLIC ACIDSpa de Soleilf81834b7-672d-4411-e053-6394a90aeada2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare CleanserSALICYLIC ACIDSpa de Soleile3514af1-f9b9-c251-e053-2a95a90ac80e2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidMEDICATED CORN REMOVERSWal-Mart Stores Inc80c4907d-d4ea-42b0-e053-2a91aa0a173c2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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