FDA.reportPublic FDA data

NDC 71399-0480-08 - SODIUM SULFACETAMIDE

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
71399-0480
Requested NDC
71399-0480-08
Package NDCs from labels
71399-0480-8, 71399-0480-2, 71399-0480-6, 71399-0480-08
Manufacturer
Akron Pharma Inc
Effective date
2024-09-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SODIUM SULFACETAMIDE - Akron Pharma IncAkron Pharma Inc2024-09-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-0480-22023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-62023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-82023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-22023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-62023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-82023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0480-2SODIUM SULFACETAMIDE360 mL in 1 BOTTLELIQUID3605
71399-0480-6SODIUM SULFACETAMIDE480 mL in 1 BOTTLELIQUID4805
71399-0480-8SODIUM SULFACETAMIDE240 mL in 1 BOTTLELIQUID2405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0480SODIUM SULFACETAMIDE LIQUID [AKRON PHARMA INC]5Current NDC, Legacy NDC, 3 package rows20240926_ba08bf7c-5fdc-447a-b8de-3f319cee7e4e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0480-2ML - Milliliter71399-0480cf4e0f2e-982f-44d6-8c99-7afc82b1e38c12019-10-07
71399-0480-6ML - Milliliter71399-048097d1299c-0b6c-43ff-b946-d3abc957227912019-02-13
71399-0480-8ML - Milliliter71399-04805d9c2b75-4ef7-4440-8fcd-f692b5a6031d12021-12-08

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 33 · 645 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Sulfacetamide SodiumSULFACETAMIDE SODIUMPreferred Pharmaceuticals, Inccf0cc763-49b5-435d-852b-e7617c8d32862026-09-02Warnings, Adverse reactionsExact identifier
unii: 4NRT660KJQ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Sulfacetamide and SulfurSODIUM SULFACETAMIDE AND SULFURAcella Pharmaceuticals, LLCc3ff4716-6009-4e29-9da9-ea740726cc3c2026-07-14Warnings, Adverse reactionsExact identifier
unii: 4NRT660KJQ
Sodium Sulfacetamide 9 Sulfur 4.5 WashSULFACETAMIDE SODIUM AND SULFURAcella Pharmaceuticals, LLCa761feea-86b6-44f0-8f9a-50d29ebb60e92026-07-14Warnings, Adverse reactionsExact identifier
unii: 4NRT660KJQ

Reported adverse events (FAERS/openFDA)#

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