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 176 of 178 · 3,544 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone AcetateHYDROCORTISONE ACETATEPatrin Pharma Inc.7c1d2c8c-26e2-432f-b983-505f259665a92021-12-22Adverse reactionsExact identifier
unii: 3X7931PO74
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Flora PlusALOE, ALUMINA, ANTIMON CRUD, ARG NIT, CHELIDONIUM MAJ, GAMBOGIA, GRAPHITES, HYDRASTIS, LYCOPODIUM, SILICEANET Remediesfc1ced48-bd9f-4b3f-b786-573fba0729752021-01-21WarningsExact identifier
unii: ZY81Z83H0X
Day and Night VitalsALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIRNET Remediesd5ddba51-5f0c-4b06-8f87-3cd6faf64b792021-01-19WarningsExact identifier
unii: ZY81Z83H0X
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand SanitizerHAND SANITIZERLS Promotions Inc.a187d9fc-e5ce-2b48-e053-2995a90a0c0e2020-12-09WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
Hydrocortisone AcetateHYDROCORTISONE ACETATEProficient Rx LP43ed7a9a-0aaf-4987-8367-e2490d1b84482020-05-07Adverse reactionsExact identifier
unii: 3X7931PO74
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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