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 22 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluocinolone acetonideFLUOCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltdba20d901-f800-4edd-aac6-6c77cbfe10642025-07-31Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
unii: N6K5787QVP
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltde6af2549-50b5-4b7f-a0c0-de0f7626b6f32025-07-31Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone acetonideFLUOCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd7f8512d9-b4a4-43c6-bac6-3e75dc451db22025-07-31Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
unii: N6K5787QVP
WISH 91% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLLJ Pharma449df7ac-97ac-41f3-a3c8-cf0d7c597e052025-07-17WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70%ISOPROPYL ALCOHOLLJ Pharmaedea3130-a766-4166-80b6-a93525f5a7372025-07-17WarningsExact identifier
unii: ND2M416302
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: N6K5787QVP
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 461225539cbe8-1d0f-41f8-9c5d-a9af7f28eed12025-07-15WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 70000bf355e30-ad2f-4f93-9d77-8efd6a908e582025-07-11WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70 Percent WintergreenISOPROPYL ALCOHOLBest Choice (Valu Merchandisers Company)abcc7941-e521-4ad6-89df-0b965b634eb32025-07-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 700005ffa8ecf-1349-4758-8d47-e9a96d2ddaee2025-07-11WarningsExact identifier
unii: ND2M416302
AerowipeALCOHOL WIPEAero Healthcare34c93704-9f3c-6746-e054-00144ff8d46c2025-07-10WarningsExact identifier
unii: ND2M416302
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDEA-S Medication Solutions0ff97af2-04d6-478e-8abe-ca5a0c6757082025-07-10Adverse reactionsExact identifier
rxcui: 1191307
unii: 0CD5FD6S2M
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213 LLCf06e4f9d-6cef-b57a-e053-2a95a90a73372025-07-03WarningsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.02352ed1-3568-441f-add8-45201351a11c2025-07-03Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.22e9909a-47d2-4331-9b92-e7c4c2acf7392025-07-02Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M

Reported adverse events (FAERS/openFDA)#

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