FDA.reportPublic FDA data

Plexion

Product NDC
44118-701
11-digit product format
441180701
Labeler code
44118
Product ID
44118-701_db71ee55-bbde-0996-e053-2a95a90a5687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Eckson Labs LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-03-30
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 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
Plexion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR98 mg/g
SULFACETAMIDE SODIUM48 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1494173Internal RxNorm lookup
1494826Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db71ee55-bbdd-0996-e053-2a95a90a5687Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44118-701-02Plexion57 g in 1 BOTTLE, PLASTICCREAM571

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44118-701-02GM - Gram44118-70143f5f4dc-ee69-444e-96cb-5d46b947eecb12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44118-701PLEXION (SULFACETAMIDE SODIUM, SULFUR) CREAM [ECKSON LABS LLC]1Current NDC, Legacy NDC, 1 package rows20220402_db71ee55-bbdd-0996-e053-2a95a90a5687.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
PlexionSULFACETAMIDE SODIUM, SULFUREckson Labs LLCdb71ee55-bbdd-0996-e053-2a95a90a56872022-03-30Warnings, Adverse reactionsExact identifier
ndc (product): 44118-701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494826Plexion 9.8 % / 4.8 % Topical CreamPSNdb71ee55-bbdd-0996-e053-2a95a90a56871
1494173sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical CreamPSNdb71ee55-bbdd-0996-e053-2a95a90a56871
1494826sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Topical Cream [Plexion]SBDdb71ee55-bbdd-0996-e053-2a95a90a56871
1494173sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Topical CreamSCDdb71ee55-bbdd-0996-e053-2a95a90a56871
1494826Plexion (sulfacetamide sodium 9.8 % / sulfur 4.8 % ) Topical CreamSYdb71ee55-bbdd-0996-e053-2a95a90a56871
1494173sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical CreamSYdb71ee55-bbdd-0996-e053-2a95a90a56871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44118-701-024411807010257 g in 1 BOTTLE, PLASTIC (44118-701-02) 57 g2022-03-300000-00-00NoNoCurrent