FDA.reportPublic FDA data

NDC 00591-0810 - Silver Sulfadiazine

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
00591-0810
Manufacturer
Keltman Pharmaceuticals Inc. | Sandhills Packaging
Effective date
2010-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Silver Sulfadiazine - Keltman Pharmaceuticals Inc. | Sandhills PackagingKeltman Pharmaceuticals Inc. | Sandhills Packaging2010-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
SILVER SULFADIAZINEACTIVE MOIETYW46JY43EJRSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56SILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2

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 23 of 40 · 789 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: A2I8C7HI9T
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMOraLabs1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea72025-05-07WarningsExact identifier
unii: 4T6H12BN9U
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
unii: 4T6H12BN9U
OraLabs ChapIce Original PetrolatumPETROLATUMOraLabs54729693-f0e2-48ad-881a-a07986ed823b2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
Sunfrog Ultra SPF 30 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYOraLabs61299626-bf60-40e8-a2d3-4d4a99d8d15c2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
unii: 4T6H12BN9U
OraLabs ChapIce Cherry PetrolatumPETROLATUMOraLabsf0d9d01e-bfdf-4e33-abfb-f683d414d8082025-04-29WarningsExact identifier
unii: 4T6H12BN9U
SPF 45 - Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMOraLabsafd10abe-1e8b-4df8-9d8c-ef15266c510c2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
OraLabs SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMOraLabs3ac8569f-4b11-4536-8919-234f79bbd7fc2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
ChapIce SPF 30 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMOraLabsc7094485-a19f-41b7-88b8-d6d472adbff12025-04-22WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
unii: 4T6H12BN9U
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: 4T6H12BN9U
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
unii: 4T6H12BN9U
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: A2I8C7HI9T

Reported adverse events (FAERS/openFDA)#

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