FDA.reportPublic FDA data

First Aid Only Povidone-Iodine Antiseptic

Product NDC
0924-8113
11-digit product format
009248113
Labeler code
0924
Product ID
0924-8113_1f93db77-6db7-9866-e063-6394a90aa068
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
PATCH
Route
TOPICAL
Labeler
Acme United Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-03
Substance
POVIDONE-IODINE
Active strength
10 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
First Aid Only Povidone-Iodine Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0052ac2-4f74-32a4-e053-2995a90a94c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-8113-00First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-01First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-01First Aid Only Povidone-Iodine Antiseptic10 in 1 CARTONPATCH102
0924-8113-02First Aid Only Povidone-Iodine Antiseptic50 in 1 CARTONPATCH502
0924-8113-02First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-03First Aid Only Povidone-Iodine Antiseptic5.5 g in 1 POUCHPATCH5.52
0924-8113-03First Aid Only Povidone-Iodine Antiseptic100 in 1 CARTONPATCH1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-8113FIRST AID ONLY POVIDONE-IODINE ANTISEPTIC (POVIDONE-IODINE) PATCH [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 7 package rows20240815_e0052ac2-4f74-32a4-e053-2995a90a94c6.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 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
application number: M003
Leader Alcohol 70 Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d2023-11-09WarningsExact identifier
application number: M003
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-8113-00009248113005.5 g in 1 POUCH (0924-8113-00) 5.5 g2022-06-030000-00-00NoNoCurrent
0924-8113-010092481130110 POUCH in 1 CARTON (0924-8113-01) / 5.5 g in 1 POUCH10 pouch2022-06-030000-00-00NoNoCurrent
0924-8113-020092481130250 POUCH in 1 CARTON (0924-8113-02) / 5.5 g in 1 POUCH50 pouch2022-06-030000-00-00NoNoCurrent
0924-8113-0300924811303100 POUCH in 1 CARTON (0924-8113-03) / 5.5 g in 1 POUCH100 pouch2024-08-19NoNoCurrent