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 92 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMy Imports USA, LLCd4d77ec3-4930-74f0-e053-2a95a90a962a2024-12-18WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA, LLCde47bf08-f64e-781d-e053-2a95a90ab08f2024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d80ae4-3fba-4605-e053-2a95a90a21192024-12-18WarningsExact identifier
application number: M003
American Red Cross 50% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCde47a879-9cd0-5fbb-e053-2a95a90a1fba2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact 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