FDA.reportPublic FDA data

Sodium Sulfacetamide

Product NDC
16477-411
Requested package NDC
16477-411-08
11-digit product format
164770411
Labeler code
16477
Product ID
16477-411_390ab477-4120-9fd3-e063-6294a90aa010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Laser Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-09-13
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
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
Sodium Sulfacetamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
832864Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
055a586a-a840-0205-e063-6394a90a44cbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16477-411-08Sodium Sulfacetamide237 mL in 1 BOTTLESHAMPOO2373
16477-411-08Sodium Sulfacetamide1 in 1 CARTONSHAMPOO13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-411-08ML - Milliliter16477-411eb7b222d-bd34-4301-9263-12ba8f174e5712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16477-411SODIUM SULFACETAMIDE SHAMPOO [LASER PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240430_055a586a-a840-0205-e063-6394a90a44cb.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
Sodium SulfacetamideSODIUM SULFACETAMIDELaser Pharmaceuticals, LLC055a586a-a840-0205-e063-6394a90a44cb2025-07-03Warnings, Adverse reactionsExact identifier
ndc (package): 16477-411-08
ndc (product): 16477-411
ndc11 (package): 16477041108

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
832864sulfacetamide sodium 10 % Medicated ShampooPSN055a586a-a840-0205-e063-6394a90a44cb3
832864sulfacetamide sodium 100 MG/ML Medicated ShampooSCD055a586a-a840-0205-e063-6394a90a44cb3
832864sulfacetamide sodium 10 % Medicated ShampooSY055a586a-a840-0205-e063-6394a90a44cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16477-411-08164770411081 BOTTLE in 1 CARTON (16477-411-08) / 237 mL in 1 BOTTLE1 bottle2023-09-13NoNoCurrent