FDA.reportPublic FDA data

NDC 81077-030-01 - SOLEP PREMIER HI GRO AMPOULE PACK

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
81077-030
Requested NDC
81077-030-01
Package NDCs from labels
81077-030-01, 81077-030-02
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 AMPOULE PACK - 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
81077-030-022025-01-30C16284748780-12cef2736-6f40-d83d-e063-dadaa90ab31f0a27152e-1118-43ea-a3a3-3a0e1b9bae2d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-030-01SOLEP PREMIER HI GRO AMPOULE PACK40 mL in 1 TUBELIQUID401
81077-030-02SOLEP PREMIER HI GRO AMPOULE PACK1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-030SOLEP PREMIER HI GRO AMPOULE PACK (PANTHENOL, MENTHOL, SALICYLIC ACID) LIQUID [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_0a27152e-1118-43ea-a3a3-3a0e1b9bae2d.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 225 of 324 · 6,469 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Tichenors First Aid AntisepticALCOHOLDr. G. H. Tichenor's Antiseptic Company9947855d-b8e0-4c22-a627-16b526242e392025-01-09WarningsExact identifier
unii: 3K9958V90M
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
unii: L7T10EIP3A
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
unii: L7T10EIP3A
Drs. ACNE CLEARSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACYd6faa57c-d081-b57c-e053-2a95a90a79262025-01-09WarningsExact identifier
unii: O414PZ4LPZ
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
unii: L7T10EIP3A
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
unii: L7T10EIP3A
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a0d53-0d4a-6dc7-e053-2a95a90acc1c2025-01-08WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTempo Industries, Inc.af9a678b-488a-7045-e053-2995a90a401c2025-01-08WarningsExact identifier
unii: 3K9958V90M
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
unii: 3K9958V90M
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
unii: 3K9958V90M
innisfree Gentle Retinol Salicylic Acne SerumSALICYLIC ACID GELInnisfree Corporation2b38b6f2-0de5-581b-e063-6394a90acd552025-01-08WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PentaCleanse Alcohol WipesALCOHOLPrestige Care Pharmacy Ince41a3e03-af01-5280-e053-2a95a90a8afc2025-01-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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