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 30 of 36 · 703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadALCOHOL PREP PADASO LLCf2a41151-a807-566c-e053-2995a90af8772024-11-01WarningsExact identifier
unii: ND2M416302
TRI-LUMAFLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOINGalderma Laboratories, L.P.a35fa709-5eb5-4429-b38f-f1e0019bf0ee2024-10-24Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Isopropyl Rubbing Alcohol 99%ISOPROPYL ALCOHOLUniversal Distribution Center LLC678a9b14-2838-4358-9673-fc23e0f58efb2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLCa9960d2f-f13a-4168-b2e9-d6f4a35d84ae2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLUniversal Distribution Center LLC5db1659e-3a13-47f0-90ae-f8f192c6111a2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC3dcdc1cc-ece8-4b47-a236-ee57c375bb992024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack8ca4528d-7afa-451e-97ae-9c1c21c07a6e2024-10-18Warnings, Adverse reactionsExact identifier
rxcui: 1191307
unii: 0CD5FD6S2M
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: N6K5787QVP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: N6K5787QVP
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLembecta Medical II, LLCe9576c62-6b6e-4c51-a162-0f93f7ffd7dd2024-09-13WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWildman Business Group1fd15c0f-7119-0712-e063-6294a90a96252024-09-01WarningsExact identifier
unii: ND2M416302
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Bryant Ranch Prepackce89966d-d7ea-4986-936e-6d46aee497cd2024-08-20Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
unii: ND2M416302
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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