FDA.reportPublic FDA data

alcohol

Product NDC
68786-120
11-digit product format
687860120
Labeler code
68786
Product ID
68786-120_47e7cac8-63dd-eced-e063-6394a90a9ba3
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-19
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/mL
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
alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.7 mL/mL

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
671e9fa9-a4b8-42a2-bd6f-490bc902a86eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-120-13alcohol10 in 1 CASESWAB1010
68786-120-13alcohol200 in 1 BOXSWAB20010
68786-120-14alcohol20 in 1 CASESWAB2010
68786-120-14alcohol100 in 1 BOXSWAB10010
68786-120-16alcohol100 in 1 BOXSWAB10010
68786-120-16alcohol10 in 1 CASESWAB1010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]4
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]4
WATERINACTIVE INGREDIENT059QF0KO0RALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-120ALCOHOL SWAB [SION BIOTEXT MEDICAL LTD]9Current NDC, Legacy NDC, 6 package rows20240111_671e9fa9-a4b8-42a2-bd6f-490bc902a86e.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 112 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN671e9fa9-a4b8-42a2-bd6f-490bc902a86e10
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD671e9fa9-a4b8-42a2-bd6f-490bc902a86e10
797544isopropyl alcohol 70 % Medicated PadSY671e9fa9-a4b8-42a2-bd6f-490bc902a86e10
797544isopropyl alcohol 70 % Topical ClothSY671e9fa9-a4b8-42a2-bd6f-490bc902a86e10
797544isopropyl alcohol 70 % Topical SwabSY671e9fa9-a4b8-42a2-bd6f-490bc902a86e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-120-136878601201310 BOX in 1 CASE (68786-120-13) / 200 POUCH in 1 BOX / 3 mL in 1 POUCH10 box2011-12-190000-00-00NoNoCurrent
68786-120-146878601201420 BOX in 1 CASE (68786-120-14) / 100 POUCH in 1 BOX / 3 mL in 1 POUCH20 box2011-12-190000-00-00NoNoCurrent
68786-120-166878601201610 BOX in 1 CASE (68786-120-16) / 100 POUCH in 1 BOX / 3 mL in 1 POUCH10 box2011-12-190000-00-00NoNoCurrent