TCX Skincare

Product NDC
49449-100
11-digit product format
494490100
Labeler code
49449
Product ID
49449-100_600612eb-7f2c-42b7-8b2a-6eb01342aa66
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Theraceutix, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-17
Substance
OATMEAL
Active strength
2 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TCX Skincare
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1189915

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49449-100-01TCX Skincare59 g in 1 JARCREAM596
49449-100-02TCX Skincare9 g in 1 JARCREAM96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663YTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
OATMEALACTIVE MOIETY8PI54V663YTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
PEG-40 STEARATEINACTIVE INGREDIENTECU18C66Q7TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49449-100TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC]3Current NDC, Legacy NDC, 2 package rows20231213_c3be950b-28cf-47c2-9570-ebd46e43b1ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSNc3be950b-28cf-47c2-9570-ebd46e43b1ba6
1189915colloidal oatmeal 20 MG/ML Topical CreamSCDc3be950b-28cf-47c2-9570-ebd46e43b1ba6
1189915colloidal oatmeal 2 % Topical CreamSYc3be950b-28cf-47c2-9570-ebd46e43b1ba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49449-100-014944901000159 g in 1 JAR (49449-100-01) 59 g2012-05-170000-00-00NoNoCurrent
49449-100-02494490100029 g in 1 JAR (49449-100-02) 9 g2012-05-170000-00-00NoNoCurrent