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 33 of 40 · 789 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
unii: 4T6H12BN9U
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
unii: 4T6H12BN9U
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
unii: 4T6H12BN9U
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions475953ba-b555-474c-9bcd-8cd314cc0d1f2024-01-31Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
unii: 4T6H12BN9U
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
unii: 4T6H12BN9U
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
unii: 4T6H12BN9U
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
unii: 4T6H12BN9U
EA EIGHT HR LIP SHEER TINTSOXYBENZONE, PADIMATE O, PETROLATUMREVLONb671d630-2b71-66d2-e053-2a95a90a84612024-01-12WarningsExact identifier
unii: 4T6H12BN9U
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCICardinal Health 110 dba LEADERa5a261c2-1f36-c895-e053-2a95a90ab22b2024-01-02WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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