FDA.reportPublic FDA data

Lone Star Botanicals Hand Sanitizer Gel

Product NDC
81225-001
11-digit product format
812250001
Labeler code
81225
Product ID
81225-001_b5568d0e-2ced-2a3c-e053-2a95a90ae9e9
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Lone Star Botannicals
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-07
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 L/100L
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct81225-001IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-01IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-02IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-03IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-04IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-05IInactivated by FDA2026-07-31
excluded packagepackage81225-00181225-001-06IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
KONIX Alcohol Antiseptic Hand RubKONIX ALCOHOL ANTISEPTIC HAND RUBTURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS17435b35-815b-4292-a809-e533ea137b802025-01-29WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove074a760f-9031-40c1-9867-95ef0345418d2025-01-08WarningsExact identifier
MistALCOHOLDerma Glove2a0bcc4e-5114-4afc-91cb-cb4816a63db22024-10-09WarningsExact identifier
HandLOTIONDerma Gloveba9611a3-e2a4-4835-9ffe-aafe85a7cb9c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove45d130c9-0835-45bb-b525-86a2119c87d12024-10-09WarningsExact identifier
MistALCOHOLDerma Gloveb5bfd7f0-0f96-459e-84d4-24b2081ae46f2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glovee2f89d56-5624-4a94-8151-1edb508232ac2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glove06f74478-57aa-4b8d-b888-55e1ee4fbd452024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloved3926f48-3a42-42df-a850-47b3914ba3b62024-10-09WarningsExact identifier
MistALCOHOLDerma Glove7c21ee1c-ce2a-464b-8269-cdb3e59db0942024-10-09WarningsExact identifier
HandLOTIONDerma Glovebcd71f37-63aa-4ad9-a9be-e5519c7e66e72024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

For external use only. Flammable. Keep away from children.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81225-001-012022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer
81225-001-022022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer
81225-001-032022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer
81225-001-042022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer
81225-001-052022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer
81225-001-062022-01-28C16284748780-1d6a99b39-7fd0-a426-e053-dadaa90af4c2Lone Star Botannicals Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81225-001-01Lone Star Botanicals Hand Sanitizer Gel0.06 L in 1 BOTTLE, PLASTICGEL0.061
81225-001-02Lone Star Botanicals Hand Sanitizer Gel0.355 L in 1 BOTTLE, PLASTICGEL0.3551
81225-001-03Lone Star Botanicals Hand Sanitizer Gel0.946 L in 1 BOTTLE, PLASTICGEL0.9461
81225-001-04Lone Star Botanicals Hand Sanitizer Gel0.06 L in 1 BOTTLE, PLASTICGEL0.061
81225-001-05Lone Star Botanicals Hand Sanitizer Gel0.355 L in 1 BOTTLE, PLASTICGEL0.3551
81225-001-06Lone Star Botanicals Hand Sanitizer Gel0.946 L in 1 BOTTLE, PLASTICGEL0.9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81225-001LONE STAR BOTANICALS HAND SANITIZER GEL (ALCOHOL) GEL LONE STAR BOTANICALS HAND SANITIZER (ALCOHOL) SOLUTION [LONE STAR BOTANNICALS]1Legacy NDC, 6 package rows20201208_b5c47625-5665-d24b-e053-2a95a90af388.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSNb5c47625-5665-d24b-e053-2a95a90af3881
1039339ethanol 80 % Topical SolutionPSNb5c47625-5665-d24b-e053-2a95a90af3881
1041498ethanol 0.8 ML/ML Topical GelSCDb5c47625-5665-d24b-e053-2a95a90af3881
1039339ethanol 0.8 ML/ML Topical SolutionSCDb5c47625-5665-d24b-e053-2a95a90af3881
1041498ethanol 80 % Topical GelSYb5c47625-5665-d24b-e053-2a95a90af3881
1039339ethanol 80 % Topical SolutionSYb5c47625-5665-d24b-e053-2a95a90af3881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81225-001-0181225000101.06 L in 1 BOTTLE, PLASTIC (81225-001-01) 2020-12-070000-00-00NoNoCurrent
81225-001-0281225000102.355 L in 1 BOTTLE, PLASTIC (81225-001-02) 2020-12-070000-00-00NoNoCurrent
81225-001-0381225000103.946 L in 1 BOTTLE, PLASTIC (81225-001-03) 2020-12-070000-00-00NoNoCurrent
81225-001-0481225000104.06 L in 1 BOTTLE, PLASTIC (81225-001-04) 2020-12-070000-00-00NoNoCurrent
81225-001-0581225000105.355 L in 1 BOTTLE, PLASTIC (81225-001-05) 2020-12-070000-00-00NoNoCurrent
81225-001-0681225000106.946 L in 1 BOTTLE, PLASTIC (81225-001-06) 2020-12-070000-00-00NoNoCurrent