FDA.reportPublic FDA data

NDC 52191-352-01 - Hydrocortisone Acetate, Iodoquinol

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
52191-352
Requested NDC
52191-352-01
Package NDCs from labels
52191-352-01, 52191-352-30
Manufacturer
Bowyn Labs, LLC
Effective date
2023-09-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Acetate, Iodoquinol - Bowyn Labs, LLCBowyn Labs, LLC2023-09-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52191-352-01GM - Gram52191-35259aee306-8a47-484b-a32d-fe99180c404b12015-07-20
52191-352-30GM - Gram52191-3526e3fd621-1575-4310-948b-8f99a62df7ef12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74HYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
IODOQUINOLACTIVE INGREDIENT63W7IE88K8HYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
IODOQUINOLACTIVE MOIETY63W7IE88K8HYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208HYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
PALMITOYL TRIPEPTIDE-1INACTIVE INGREDIENTHO4ZT5S86CHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
PPG-20 METHYL GLUCOSE ETHERINACTIVE INGREDIENT3WV1T97D3KHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ACETATE, IODOQUINOL CREAM [BOWYN LABS, LLC]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 175 of 178 · 3,544 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd982f0862-2be8-4a65-8b61-8f3a95ab59512022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd87a4c494-56f9-48f6-8592-d610c507a4fc2022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEPadagis US LLC2fdb9940-6da8-49b0-a236-9817943f7a4b2022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
unii: ZY81Z83H0X
Hydrocortisone AcetateHYDROCORTISONE ACETATEAPNAR PHARMA LPcb60f2a6-8bab-c0f9-e053-2a95a90a422a2022-03-16Adverse reactionsExact identifier
unii: 3X7931PO74
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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