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 104 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nourishing Hand Sanitizer LimonALCOHOLNoshinkud70fba7a-513f-0341-e053-2a95a90add862024-05-15WarningsExact identifier
application number: M003
Nourishing Hand Sanitizer VetiverALCOHOLNoshinkud70fb84c-fdbc-6ba8-e053-2995a90ab5292024-05-15WarningsExact identifier
application number: M003
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact 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