FDA.reportPublic FDA data

Alcohol wipes

Product NDC
80538-001
11-digit product format
805380001
Labeler code
80538
Product ID
80538-001_b041da68-bf49-dad7-e053-2a95a90a22c6
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol wipes
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jiangyin Yunzhi Medical Non-woven Products Co., Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/1001
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 productproduct80538-001IInactivated by FDA2026-07-31
excluded packagepackage80538-00180538-001-01IInactivated by FDA2026-07-31
excluded packagepackage80538-00180538-001-02IInactivated by FDA2026-07-31
excluded packagepackage80538-00180538-001-03IInactivated 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
80538-001-012021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes
80538-001-022021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes
80538-001-032021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80538-001-01Alcohol wipes60 in 1 BAGCLOTH601
80538-001-02Alcohol wipes320 in 1 BAGCLOTH3201
80538-001-03Alcohol wipes750 in 1 BAGCLOTH7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80538-001ALCOHOL WIPES CLOTH [JIANGYIN YUNZHI MEDICAL NON-WOVEN PRODUCTS CO., LTD]1Legacy NDC, 3 package rows20200927_b0422782-6b87-2f66-e053-2a95a90ac55e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80538-001-018053800010160 CLOTH in 1 BAG (80538-001-01) 60 cloth2020-03-300000-00-00NoNoCurrent
80538-001-0280538000102320 CLOTH in 1 BAG (80538-001-02) 320 cloth2020-03-300000-00-00NoNoCurrent
80538-001-0380538000103750 CLOTH in 1 BAG (80538-001-03) 750 cloth2020-03-300000-00-00NoNoCurrent