FDA.reportPublic FDA data

Sumaxin

Product NDC
43538-100
Requested package NDC
43538-100-60
11-digit product format
435380100
Labeler code
43538
Product ID
43538-100_10983826-2970-4ff2-87f6-6633c093843f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and Sulfur
Dosage form
CLOTH
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-01-01
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 40 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sumaxin
Brand name suffix
Cleansing Pads
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000946Internal RxNorm lookup
1000976Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5d9ddc1a-fbae-4595-86ce-3bbca7d03482Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43538-100-602023-12-15C16284748780-10191ceaa-704c-198a-e063-dbdaa90aec3esumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads
43538-100-602023-07-28C16284748780-10191ceaa-704c-198a-e063-dbdaa90aec3esumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-100-60Sumaxin Cleansing Pads60 in 1 CARTONCLOTH603
43538-100-60Sumaxin Cleansing Pads3.7 g in 1 PACKETCLOTH3.73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-100-60EA - Each43538-1007a5ff65d-0345-42fe-85b1-bac3b57c4a8b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQSUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
sulfurACTIVE INGREDIENT70FD1KFU70SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
sulfacetamideACTIVE MOIETY4965G3J0F5SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
sulfurACTIVE MOIETY70FD1KFU70SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-100SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20231216_5d9ddc1a-fbae-4595-86ce-3bbca7d03482.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumaxin Cleansing PadsSULFACETAMIDE SODIUM AND SULFURMedimetriks Pharmaceuticals, Inc.5d9ddc1a-fbae-4595-86ce-3bbca7d034822023-12-15Warnings, Adverse reactionsExact identifier
ndc (package): 43538-100-60
ndc (product): 43538-100
ndc11 (package): 43538010060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000946sulfacetamide sodium 10 % / sulfur 4 % Medicated PadPSN5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000976Sumaxin CP 10 % / 4 % Medicated PadPSN5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000976sulfacetamide sodium 100 MG/ML / sulfur 40 MG/ML Medicated Pad [Sumaxin]SBD5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000946sulfacetamide sodium 100 MG/ML / sulfur 40 MG/ML Medicated PadSCD5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000946sulfacetamide sodium 10 % / sulfur 4 % Medicated PadSY5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000946sulfacetamide sodium 10 % / sulfur 4 % Topical SwabSY5d9ddc1a-fbae-4595-86ce-3bbca7d034823
1000976Sumaxin CP (sulfacetamide sodium 10 % / sulfur 4 % ) Medicated PadSY5d9ddc1a-fbae-4595-86ce-3bbca7d034823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-100-604353801006060 PACKET in 1 CARTON (43538-100-60) / 3.7 g in 1 PACKET60 packet2009-01-010000-00-00NoNoCurrent