FDA.reportPublic FDA data

NDC 53499-0390-04 - Florasone

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
53499-0390
Requested NDC
53499-0390-04
Package NDCs from labels
53499-0390-4, 53499-0390-04
Manufacturer
Schwabe North America | Schwabe Mexico, S.A. de C.V.
Effective date
2025-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FlorasoneSchwabe North America | Schwabe Mexico, S.A. de C.V.2025-11-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-0390-4Florasone1 in 1 CARTONCREAM112
53499-0390-4Florasone28 g in 1 TUBECREAM2812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-0390FLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [SCHWABE NORTH AMERICA]11Current NDC, Legacy NDC, 2 package rows20241210_0ea5879c-5955-427d-8604-a0677a4bb5cd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARDIOSPERMUM HALICACABUM FLOWERING TOPACTIVE INGREDIENTMZP2508BRRFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
CARDIOSPERMUM HALICACABUM FLOWERING TOPACTIVE MOIETYMZP2508BRRFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
STEARYL HEPTANOATEINACTIVE INGREDIENT2M4UGL1NCNFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLORASONE (CARDIOSPERMUM HALICACABUM FLOWERING TOP) CREAM [NATURES WAY HOLDING CO.]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 1 of 170 · 3,385 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
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
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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