FDA.reportPublic FDA data

DermaWound Wound Care Venous Stasis

Product NDC
57554-120
11-digit product format
575540120
Labeler code
57554
Product ID
57554-120_0c870cce-24cb-9f40-e063-6394a90a0c76
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine hydrochloride
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Progressive Doctors, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-01
Substance
BENZOCAINE
Active strength
1.27 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 Venous Stasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE1.27 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1552221Internal RxNorm lookup
1552226Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6221ba86-8b7f-48c8-8284-6950f9fc36b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57554-120-06DermaWound Wound Care Venous Stasis179 g in 1 TUBEOINTMENT1795
57554-120-06DermaWound Wound Care Venous Stasis1 in 1 CARTONOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5DERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5DERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
POVIDONE-IODINEINACTIVE INGREDIENT85H0HZU99MDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [WOUND CARE USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57554-120DERMAWOUND WOUND CARE VENOUS STASIS (BENZOCAINE HYDROCHLORIDE) OINTMENT [PROGRESSIVE DOCTORS, LLC]5Current NDC, Legacy NDC, 2 package rows20231215_6221ba86-8b7f-48c8-8284-6950f9fc36b1.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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1552221benzocaine HCl 1.27 % Topical OintmentPSN6221ba86-8b7f-48c8-8284-6950f9fc36b15
1552226DermaWound Venous Stasis Formula 1.27 % Topical OintmentPSN6221ba86-8b7f-48c8-8284-6950f9fc36b15
1552226benzocaine hydrochloride 0.0127 MG/MG Topical Ointment [Dermawound Benzocaine]SBD6221ba86-8b7f-48c8-8284-6950f9fc36b15
1552221benzocaine hydrochloride 0.0127 MG/MG Topical OintmentSCD6221ba86-8b7f-48c8-8284-6950f9fc36b15
1552221benzocaine hydrochloride 1.27 % Topical OintmentSY6221ba86-8b7f-48c8-8284-6950f9fc36b15
1552226Dermawound Benzocaine 1.27 % Topical OintmentSY6221ba86-8b7f-48c8-8284-6950f9fc36b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57554-120-06575540120061 TUBE in 1 CARTON (57554-120-06) / 179 g in 1 TUBE1 tube2014-02-020000-00-00NoNoCurrent