FDA.reportPublic FDA data

Singular Wipes Unscented

Product NDC
81428-080
11-digit product format
814280080
Labeler code
81428
Product ID
81428-080_49645b37-9e54-e645-e063-6394a90a395b
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
SINGULAR ENTERPRISES LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 Unscented
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac2b352f-6cb2-4683-bb41-13e8ecb186bfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81428-080-01Singular Wipes Unscented30 in 1 BOXCLOTH301
81428-080-01Singular Wipes Unscented4 mL in 1 POUCHCLOTH41
81428-080-02Singular Wipes Unscented100 in 1 BOXCLOTH1001
81428-080-02Singular Wipes Unscented4 mL in 1 POUCHCLOTH41

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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNac2b352f-6cb2-4683-bb41-13e8ecb186bf1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDac2b352f-6cb2-4683-bb41-13e8ecb186bf1
797544isopropyl alcohol 70 % Medicated PadSYac2b352f-6cb2-4683-bb41-13e8ecb186bf1
797544isopropyl alcohol 70 % Topical ClothSYac2b352f-6cb2-4683-bb41-13e8ecb186bf1
797544isopropyl alcohol 70 % Topical SwabSYac2b352f-6cb2-4683-bb41-13e8ecb186bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81428-080-018142800800130 POUCH in 1 BOX (81428-080-01) / 4 mL in 1 POUCH30 pouch2026-05-01NoNoCurrent
81428-080-0281428008002100 POUCH in 1 BOX (81428-080-02) / 4 mL in 1 POUCH100 pouch2026-05-01NoNoCurrent