FDA.reportPublic FDA data

DermaWound Wound Care

Product NDC
57554-110
11-digit product format
575540110
Labeler code
57554
Product ID
57554-110_0c86d49a-27f1-7f18-e063-6394a90ad534
Type
HUMAN OTC DRUG
Nonproprietary name
povidone-iodine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Progressive Doctors, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-08
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
DermaWound Wound Care
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312563Internal RxNorm lookup
1432885Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d49daa7-aa02-4219-880b-e1697bde8a7eAvailable 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
57554-110-06DermaWound Wound Care179 g in 1 TUBEOINTMENT1795
57554-110-06DermaWound Wound Care1 in 1 CARTONOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
IODINEACTIVE MOIETY9679TC07X4DERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [WOUND CARE USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57554-110DERMAWOUND WOUND CARE (POVIDONE-IODINE) OINTMENT [PROGRESSIVE DOCTORS, LLC]5Current NDC, Legacy NDC, 2 package rows20231215_2d49daa7-aa02-4219-880b-e1697bde8a7e.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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1432885DermaWound Professional Care Wound Care 10 % Topical OintmentPSN2d49daa7-aa02-4219-880b-e1697bde8a7e5
312563povidone-iodine 10 % Topical OintmentPSN2d49daa7-aa02-4219-880b-e1697bde8a7e5
1432885povidone-iodine 0.1 MG/MG Topical Ointment [Dermawound]SBD2d49daa7-aa02-4219-880b-e1697bde8a7e5
312563povidone-iodine 0.1 MG/MG Topical OintmentSCD2d49daa7-aa02-4219-880b-e1697bde8a7e5
1432885Dermawound (povidone-iodine 10 % (available iodine 0.65 % )) Topical OintmentSY2d49daa7-aa02-4219-880b-e1697bde8a7e5
1432885Dermawound (povidone-iodine 10 % ) Topical OintmentSY2d49daa7-aa02-4219-880b-e1697bde8a7e5
1432885Dermawound 0.1 MG/MG Topical OintmentSY2d49daa7-aa02-4219-880b-e1697bde8a7e5
312563povidone-iodine 10 % (equal to 1 % available iodine) Topical OintmentSY2d49daa7-aa02-4219-880b-e1697bde8a7e5
312563povidone-iodine 10 % Topical OintmentSY2d49daa7-aa02-4219-880b-e1697bde8a7e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57554-110-06575540110061 TUBE in 1 CARTON (57554-110-06) / 179 g in 1 TUBE1 tube2013-04-080000-00-00NoNoCurrent