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 6 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mederma PM DIMETHICONE PMI Branded Pharmaceuticals, Inc. 26737285-f6ae-47eb-9019-33f1cfce3029 2026-07-15 Warnings Exact identifier application number: M016 MEDERMA STRETCH MARKS THERAPY DIMETHICONE L. Perrigo Company e9366775-e85b-4403-a2c5-12d9fb3cc3fa 2026-07-15 Warnings Exact identifier application number: M016 Remedy Barrier Cream Cloths Fragrance Free DIMETHICONE Medline Industries, LP 00e0cd4a-6049-408a-ab3f-9edf97e6438a 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 3e61191a-e0fa-3477-e063-6294a90a7d19 2026-07-14 Warnings Exact identifier application number: M016 Cruex Petroleum Jelly WHITE PETROLATUM MKJ BRANDS LLC 459a90b8-7d52-ef70-e063-6394a90ac1d0 2026-07-14 Warnings Exact identifier application number: M016 Mederma for Kids ALLANTOIN L. Perrigo Company ed4ff435-9819-46d3-9375-914712943f77 2026-07-14 Warnings Exact identifier application number: M016 Baby 3-in-1 Diaper Rash BABY 3-IN-1 DIAPER RASH Walgreens 5632dde2-f59d-3a45-e063-6394a90a1a24 2026-07-09 Warnings Exact identifier application number: M016 Drs. DIAPER RASH MAXIMUM STRENGTH ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 161ba174-1b13-83cd-e063-6394a90af19c 2026-07-09 Warnings Exact identifier application number: M016 Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Exact identifier application number: M016 SOHEJU Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 560089ff-3361-90b7-e063-6294a90ada42 2026-07-09 Warnings Exact identifier application number: M016 Bee Venom Psoriasis Wart Caring Cream GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 563a423c-e9dd-1cab-e063-6294a90a8c6a 2026-07-09 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson Medical-Surgical Inc. 46df52c8-0cbf-213e-e054-00144ff88e88 2026-07-08 Warnings Exact identifier application number: M016 Skin Protectant with Lanolin LANOLIN McKesson 5abe1b34-f71b-2a90-e053-2991aa0aded6 2026-07-08 Warnings Exact identifier application number: M016 Walgreens Baby Healing Balm PETROLATUM Walgreens 561c1e1e-e896-d6e9-e063-6394a90ac0e7 2026-07-08 Warnings Exact identifier application number: M016 AD Overnight Healing AD OVERNIGHT HEALING WellSpring Pharmaceutical Corporation 57c29db6-da0c-4b28-86c0-6ac1b7122428 2026-07-07 Warnings Exact identifier application number: M016 EczeNourish Eczema and Psoriasis Soothing Oat COLLOIDAL OATMEAL Vanguard Soap, LLC 55f7137f-c5a5-f2ce-e063-6394a90a5280 2026-07-07 Warnings Exact identifier application number: M016 FDS intimate Whole Body Medicated Chafing FDS INTIMATE WHOLE BODY MEDICATED CHAFING WellSpring Pharmaceutical Corporation ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c 2026-07-07 Warnings Exact identifier application number: M016 AD First Aid Multipurpose AD FIRST AID MULTIPURPOSE WellSpring Pharmaceutical Corporation 999989d8-21c2-4380-b4c1-e5421189f6ed 2026-07-07 Warnings Exact identifier application number: M016 AD Anti-Chafing AD ANTI-CHAFING WellSpring Pharmaceutical Corporation d272ab4a-eb18-4f64-b925-fccf637dbb02 2026-07-06 Warnings Exact identifier application number: M016 ECZEMA NOURISH MEDICATED CLEANSING BAR COLLOIDAL OATMEAL SKIN PROTECTANT Vanguard Soap, LLC 55f865dc-d88e-fe2f-e063-6294a90aa7d3 2026-07-06 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