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 12 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLCariba International001c1fcf-2808-467c-86d8-c038513fa3b52026-01-29WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLCariba International483586f4-aab4-40c2-8925-c4f7fb22c6aa2026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC49552e29-7813-4726-b15d-63bd975b65882026-01-28Adverse reactionsExact identifier
unii: 0CD5FD6S2M
IluvienFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.4400e471-7402-11df-93f2-0800200c9a662026-01-28Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEFougera Pharmaceuticals, LLC5649e15a-6a7c-4752-ac28-01e453afb37e2026-01-28Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Singular Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCac2b352f-6cb2-4683-bb41-13e8ecb186bf2026-01-27WarningsExact identifier
unii: ND2M416302
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
unii: ND2M416302
EVERLIT SURVIVAL PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a03ed81-5b1d-172e-e063-6394a90ac59c2026-01-23WarningsExact identifier
unii: ND2M416302
Rite Aid Isopropyl Alcohol WipesISOPROPYL ALCOHOLRite Aidbca837b0-5044-4e97-e053-2a95a90a13af2026-01-22WarningsExact identifier
unii: ND2M416302
FLUOCINOLONE ACETONIDE OilFLUOCINOLONE ACETONIDERISING PHARMA HOLDINGS, INC.f4a58ecc-cd50-4414-add1-a82b09da20582026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1191307
unii: 0CD5FD6S2M
Lights Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4905a27c-6cf8-4b1a-a02c-4c81756e8c0a2026-01-21WarningsExact identifier
unii: ND2M416302
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact identifier
unii: ND2M416302
DOP Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLOmega & Delta Co., Inc.c779a35b-1118-4560-8d77-6878edb4c2672026-01-21WarningsExact identifier
unii: ND2M416302
NEXXGEN 50% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCd48232ab-ab55-488a-9cc1-77c8d0ba992e2026-01-16WarningsExact identifier
unii: ND2M416302
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
unii: N6K5787QVP
Alcohol Prep AwabsISOPROPYL ALCOHOLEnlightening Pallet Industry Co., Limited26c7db1e-86a9-8765-e063-6294a90a634f2026-01-14WarningsExact identifier
unii: ND2M416302
Kroger 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLThe Kroger, Co.6ad6fd54-42a4-472a-bb00-95f1224e8f4e2026-01-13WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDealMed Medical Supplies LLC04e6edb5-07ef-4ed4-ba68-ed183386b5ab2026-01-13WarningsExact identifier
unii: ND2M416302
Vis Guard Lubricant EyeOintment PMMINERAL OIL, WHITE PETROLATUM OINTMENTUlai Health LLC1040a92b-d342-a9fd-e063-6294a90a45ef2026-01-13WarningsExact identifier
unii: N6K5787QVP
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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