FDA.reportPublic FDA data

NDC 28105-149 - Derma-Smoothe/FS

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
28105-149
Manufacturer
Physicians Total Care, Inc.
Effective date
2012-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Derma-Smoothe/FS ® fluocinolone acetonide Topical Oil, 0.01% (Scalp Oil)Physicians Total Care, Inc.2012-06-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28105-149-04ML - Milliliter28105-149ab88b426-b9e8-47d5-8df6-b0a4e00dee1312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
light mineral oilINACTIVE INGREDIENTN6K5787QVPDERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
OLETH-2INACTIVE INGREDIENT7L6R1SQ6M0DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1
peanut oilINACTIVE INGREDIENT5TL50QU0W4DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE) OIL [PHYSICIANS TOTAL CARE, INC.]1

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 9 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
50% Isopropyl AlcoholISOPROPYL ALCOHOLH E B0ed762dd-9432-45b4-9e75-c24fb28ff9562026-02-24Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Sunvine 70 Isopropyl Alcohol First Aid AntisepticISOPROPYL ALCOHOLMac Innovations, LLC8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c762026-02-24WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact identifier
unii: ND2M416302
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
unii: ND2M416302
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.622c9804-0be0-4dec-a6ba-5cf4b5578a842026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M
YUTIQFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.f270cad8-ed82-4969-b785-831a1910bfa62026-02-19Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Bryant Ranch Prepack3fa4d5db-b17f-44dc-aa6a-50934d42c68d2026-02-18Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Isopropyl AlcoholISOPROPYL ALCOHOLTarget Corporationb5455e53-2b86-48e7-a479-664f6601bab72026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLTarget Corporation4db7c9cb-021d-463a-9ff6-91ae42f0311d2026-02-18Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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