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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
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
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