FDA.reportPublic FDA data

NDC 28109-010-01 - AcneWorx

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
28109-010
Requested NDC
28109-010-01
Package NDCs from labels
28109-010-01, 28109-010-06
Manufacturer
DermWorx Incorporated | IGI Laboratories, Inc.
Effective date
2010-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AcneWorx® Gentle Moisturizing Clear Acne Treatment Gel (2% Salicylic Acid)DermWorx Incorporated | IGI Laboratories, Inc.2010-02-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
28109-010-062019-10-21C16284748780-1956f9ecf-c2a6-621f-e053-dbdaa90a74adAcneWorx® Gentle Moisturizing Clear Acne Treatment Gel (2% Salicylic Acid)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28109-010-01AcneWorx1 in 1 CARTONGEL11
28109-010-01AcneWorx30 mL in 1 TUBEGEL301
28109-010-06AcneWorx6 in 1 CARTONGEL61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28109-010ACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1Legacy NDC, 3 package rows20100223_43c8f760-7c5c-407c-91ce-674bd13b4ecd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1

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 7 of 73 · 1,453 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
salicylic acidSALICYLIC ACIDChain Drug Marketing Association4dc96074-50a1-baa8-e063-6294a90a5aab2026-07-22Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SANUSCODE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a0a7a7b-91e9-49f4-e063-6394a90a24622026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SANUSCODE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a0df8d0-d230-7c43-e063-6294a90a54bf2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
Ouamvh SKIN TAG REMOVERSALICYLIC ACID 20% SKIN TAG REMOVERJiangxi Yudexi Pharmaceutical Co., LTD .50915164-112a-bf71-e063-6294a90a07542026-07-21WarningsExact identifier
unii: O414PZ4LPZ
wart remover patchesWART REMOVER PATCHESShenzhen Hengdasheng Technology Co., Ltd571f815a-e448-6c41-e063-6394a90a6e112026-07-21WarningsExact identifier
unii: O414PZ4LPZ
Pureskin wart removerSALICYLIC ACIDBENLONG HALL LLC57271ece-36ef-1fa7-e063-6294a90a727a2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SYLVIRENE Liquid Wart Corn Callus RemoverSALICYLIC ACID 17% LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a367127-8b5a-4f55-e063-6294a90a1a7e2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SYLVIRENE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a3751f8-2365-1b34-e063-6394a90acf742026-07-21WarningsExact identifier
unii: O414PZ4LPZ
REINREUDE WART REMOVAERSALICYLIC ACID 17% WART REMOVAERJiangxi Yudexi Pharmaceutical Co., LTD4a38ac58-27fe-d26c-e063-6294a90a4efc2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
REINREUDE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a39b608-8789-cbbc-e063-6394a90add562026-07-21WarningsExact identifier
unii: O414PZ4LPZ
REINREUDE TAG WART REMOVERSALICYLIC ACID 40% TAG WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a45b165-5fcd-04f2-e063-6294a90ab0d42026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SERYNTH Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4b5f08-3265-ecb2-e063-6294a90a3edf2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SERYNTH GENITAL WARTS REMOVERSALICYLIC ACID 17% GENITAL WARTS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4b8c9d-a9c0-f0a1-e063-6294a90ad9dd2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
unii: O414PZ4LPZ
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
unii: O414PZ4LPZ
NATUHEAL WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a46ca4f-19df-f148-e063-6394a90a63e62026-07-20WarningsExact identifier
unii: O414PZ4LPZ
OURUI ONE WART COMPLETE Care Kit CORN WART REMOVERSALICYLIC ACID 17% WART COMPLETE CARE KIT CORN WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a47a2ff-4924-eedc-e063-6394a90ab0722026-07-20WarningsExact identifier
unii: O414PZ4LPZ
WELLREME Wart RemoverSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5e6517-fbe2-0da8-e063-6294a90ad00d2026-07-20WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.