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 153 of 330 · 6,595 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Salicylic AcidLIQUID WART REMOVERVALU MERCHANDISERS, CO920315f2-6a1c-4b9e-9771-cafdfcfd8ca02025-11-24WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVER GEL TUBEVALU MERCHANDISERS, COa047de20-3ef4-44df-b34e-e832a1b1d7aa2025-11-24WarningsExact identifier
unii: O414PZ4LPZ
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.002db658-6b1f-ea49-e063-6294a90ae3e72025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.002997d0-3176-3918-e063-6294a90a44082025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
unii: L7T10EIP3A
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
unii: L7T10EIP3A
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
unii: L7T10EIP3A
Lerna Antiseptic Sanitizing Hand GelALCOHOLLernapharm Loris Inc.444f3c7e-8403-1385-e063-6294a90a253b2025-11-23WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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