Home NDC 49449-100 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 49449-100 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49449-100 49449-100-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49449-100 49449-100-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TCX Skincare
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1189915 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49449-100-01 TCX Skincare 59 g in 1 JAR CREAM 59 6 49449-100-02 TCX Skincare 9 g in 1 JAR CREAM 9 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OATMEAL ACTIVE INGREDIENT 8PI54V663Y TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 OATMEAL ACTIVE MOIETY 8PI54V663Y TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 CETYL PALMITATE INACTIVE INGREDIENT 5ZA2S6B08X TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 GLYCERYL 1-STEARATE INACTIVE INGREDIENT 258491E1RZ TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 PEG-40 STEARATE INACTIVE INGREDIENT ECU18C66Q7 TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49449-100 TCX SKINCARE (COLLOIDAL OATMEAL) CREAM [THERACEUTIX, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20231213_c3be950b-28cf-47c2-9570-ebd46e43b1ba.zip
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 51 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016 Blistex Ivarest Poison Ivy Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Blistex Inc. e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a 2024-12-11 Warnings Exact identifier application number: M016 Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE Blistex Inc 11c0e084-dc40-4969-a176-3af4116d6f27 2024-12-10 Warnings Exact identifier application number: M016 BOA VIDA Recovery Creme DIMETHICONE Central Solutions Inc bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Canopy DIMETHICONE Central Solutions Inc 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf 2024-12-09 Warnings Exact identifier application number: M016 DermaCen Skin Protectant ZINC OXIDE Central Solutions Inc 990c3a65-bca5-1f0d-e053-2995a90aa7ae 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Calvida ZINC OXIDE Central Solutions Inc 48eb2031-bc80-45d5-b8b3-cc08fcab64f1 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Cleansing DIMETHICONE Central Solutions Inc 0b456b20-ab06-4adf-b5f0-1693d33979df 2024-12-09 Warnings Exact identifier application number: M016 SOOTHE Sensitive Skin Treatment ALLANTOIN, DIMETHICONE Rodan & Fields 2bd8cac4-5f40-4d04-91f2-3ea8a138033b 2024-12-09 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment COLLOIDAL OATMEAL Kenvue Brands LLC f67e528a-b822-3f7a-e053-2995a90ae733 2024-12-06 Warnings Exact identifier application number: M016 Humphreys Maravilla WITCH HAZEL Humphreys Pharmacal, Incorporated 7d403bf4-8a0d-4337-8e81-1149cd0ae1dc 2024-12-06 Warnings Exact identifier application number: M016 Skin Soothing Cream COLLOIDAL OATMEAL Allure Labs Inc 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3 2024-12-05 Warnings Exact identifier application number: M016 Skin Soothing Cream - Nut Free COLLOIDAL OATMEAL Allure Labs b5eb48a5-e884-3bf6-e053-2a95a90abb97 2024-12-05 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49449-100-01 49449010001 59 g in 1 JAR (49449-100-01) 59 g 2012-05-17 0000-00-00 No No Current 49449-100-02 49449010002 9 g in 1 JAR (49449-100-02) 9 g 2012-05-17 0000-00-00 No No Current