FDA.reportPublic FDA data

Singular Wipes

Product NDC
81428-070
11-digit product format
814280070
Labeler code
81428
Product ID
81428-070_36e6b2ce-d188-9c90-e063-6394a90a4566
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
SINGULAR ENTERPRISES LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-21
Marketing end
2028-01-31
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Singular Wipes

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03957345-ccd0-4def-b528-7733e6a24cbbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
81428-070-042024-08-0203957345-ccd0-4def-b528-7733e6a24cbb
81428-070-052024-08-0203957345-ccd0-4def-b528-7733e6a24cbb
81428-070-062024-08-0203957345-ccd0-4def-b528-7733e6a24cbb
81428-070-072024-08-0203957345-ccd0-4def-b528-7733e6a24cbb
81428-070-082024-08-0203957345-ccd0-4def-b528-7733e6a24cbb
81428-070-042024-07-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-052024-07-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-062024-07-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-072024-07-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-082024-07-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-042024-01-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-052024-01-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-062024-01-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-072024-01-3003957345-ccd0-4def-b528-7733e6a24cbb
81428-070-082024-01-3003957345-ccd0-4def-b528-7733e6a24cbb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81428-070-04Singular Wipes4 mL in 1 POUCHCLOTH49
81428-070-05Singular Wipes24 in 1 BOXCLOTH249
81428-070-05Singular Wipes4 mL in 1 POUCHCLOTH49
81428-070-06Singular Wipes24 in 1 BAGCLOTH249
81428-070-06Singular Wipes4 mL in 1 POUCHCLOTH49
81428-070-07Singular Wipes4 mL in 1 POUCHCLOTH49
81428-070-07Singular Wipes100 in 1 BOXCLOTH1009
81428-070-08Singular Wipes15 in 1 BOXCLOTH159
81428-070-08Singular Wipes4 mL in 1 POUCHCLOTH49

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81428-070SINGULAR WIPES (ALCOHOL) CLOTH [SINGULAR ENTERPRISES LLC]8Current NDC, Legacy NDC, 9 package rows20240805_03957345-ccd0-4def-b528-7733e6a24cbb.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 27 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diabetic First Aid GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELavior Pharma Inc.bda875e6-06bd-930f-e053-2995a90ab1972026-03-26WarningsExact identifier
application number: M003
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
application number: M003
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLMY IMPORTS USA LLC4dbe636b-f376-7e30-e063-6394a90a722b2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLMY IMPORTS USA LLC4dbe7020-e302-8706-e063-6394a90abe7c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLMY IMPORTS USA LLC4dbe79d2-ee73-a8ed-e063-6394a90a7db52026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLMY IMPORTS USA LLC4dbe8d3f-afac-cc82-e063-6294a90ae3092026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489307ethanol 70 % Medicated PadPSN03957345-ccd0-4def-b528-7733e6a24cbb9
1489307ethanol 0.7 ML/ML Medicated PadSCD03957345-ccd0-4def-b528-7733e6a24cbb9
1489307ethanol 70 % Medicated PadSY03957345-ccd0-4def-b528-7733e6a24cbb9
1489307ethanol 70 % Medicated WipesSY03957345-ccd0-4def-b528-7733e6a24cbb9
1489307ethyl alcohol 70 % ClothSY03957345-ccd0-4def-b528-7733e6a24cbb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81428-070-04814280070044 mL in 1 POUCH (81428-070-04) 4 ml2022-04-212028-01-31NoNoCurrent
81428-070-058142800700524 POUCH in 1 BOX (81428-070-05) / 4 mL in 1 POUCH24 pouch2022-04-212028-01-31NoNoCurrent
81428-070-068142800700624 POUCH in 1 BAG (81428-070-06) / 4 mL in 1 POUCH24 pouch2022-04-212028-01-31NoNoCurrent
81428-070-0781428007007100 POUCH in 1 BOX (81428-070-07) / 4 mL in 1 POUCH100 pouch2022-04-212028-01-31NoNoCurrent
81428-070-088142800700815 POUCH in 1 BOX (81428-070-08) / 4 mL in 1 POUCH15 pouch2023-10-012028-01-31NoNoHistorical