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 14 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry LIP BALM SKIN PROTECTANT Suave Brands Company 47a2487d-b2e5-7195-e063-6394a90ae481 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512b5a0-ce1f-c53e-e063-6294a90a56b6 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42770fff-d70a-d9d1-e063-6294a90aa98d 2026-03-30 Warnings Exact identifier application number: M016 Aveeno Skin Relief Healing GLYCERIN Kenvue Brands LLC 345fdde5-700b-7103-e063-6394a90a0e3e 2026-03-27 Warnings Exact identifier application number: M016 Critic Aid Clear PETROLATUM Coloplast Corp 0b6da97e-519b-4579-9895-f4ede5c48b47 2026-03-27 Warnings Exact identifier application number: M016 Baza Protect ZINC OXIDE AND DIMETHICONE Coloplast Corp 256dfcfc-a91c-49b0-9439-452586a0880e 2026-03-27 Warnings Exact identifier application number: M016 Sween 24 DIMETHICONE Coloplast Corp a623c8d7-8db0-410a-9980-02ac02f7b6ea 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect Odor Control DIMETHICONE Coloplast Corp ca5fa4ae-c18d-4457-b520-4a9318ea821f 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect DIMETHICONE Coloplast Corp 82eff041-0c9d-4261-a6b6-5a041a660074 2026-03-27 Warnings Exact identifier application number: M016 Baza Clear PETROLATUM Coloplast Corp 69d9f456-1a35-4146-8366-c0285648a172 2026-03-27 Warnings Exact identifier application number: M016 Vitamin A D LANOLIN, PETROLATUM Topco Associates LLC 5126fdf6-5df5-474b-bc0d-3a82dea61abb 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Advanced Healing PETROLATUM Amazon.com Services LLC cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Dynashield with Dimethicone ZINC OXIDE Dynarex Corporation b5dcf9e8-4689-4a08-ae73-3a859b4cbffe 2026-03-26 Warnings Exact identifier application number: M016 Eczema Relief Cream COLLOIDAL OATMEAL Lavior Pharma Inc bdd2fc9f-2718-1d88-e053-2995a90a8682 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f2dec8-7ffc-fc3e-e063-6294a90a76ff 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f33001-7fec-682e-e063-6394a90a9428 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f3b300-f32f-8881-e063-6394a90a1a2a 2026-03-26 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Dynarex Corporation 81f5092d-0632-bf47-e053-2991aa0ac563 2026-03-25 Warnings Exact identifier application number: M016 MYEVER ESTRIOL CREAM Hubei Redrui Building Materials Co., Ltd. 3ed85485-a441-4c05-e063-6394a90afef5 2026-03-25 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