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 62 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Healing PETROLATUM Galderma Laboratories, L.P. e996db17-bd4d-4b06-bb9a-983dbdec8022 2024-03-13 Warnings Exact identifier application number: M016 Diaper Rash Cream 2oz ZINC OXIDE Rejoice International Corp. 130a06a7-3360-afed-e063-6294a90ac19f 2024-03-06 Warnings Exact identifier application number: M016 mama bear DIAPER RASH Skin Protectant LANOLIN AND PETROLATUM AMAZON.COM SERVICES LLC cda9ca47-b668-4a65-908d-80b9a6515bd7 2024-03-06 Warnings Exact identifier application number: M016 Dermachange Scar ALLANTOIN Private Label Beauty and Wellness 12eed473-10d6-49c8-e063-6394a90afb63 2024-03-05 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched PETROLEUM Rejoice International 580d76ee-ea89-426e-bd25-7a58481e9795 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Creamy Petroleum Jelly Vitamin E enriched PETROLATUM Rejoice International 2c382a50-93d2-4d28-b7a4-1702b20b7139 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Foaming Facial Cleanser TRICLOSAN Rejoice International 313fcd4a-8641-417e-bf0b-02359ad815fe 2024-02-28 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Berry Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 827365b3-b3a5-4472-9add-f822362c4731 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 8b4160ed-8889-4e3a-947f-a56c3324dbbe 2024-02-09 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM, ZINC OXIDE Medline Industries, LP 101b9933-c2b8-0fdd-e063-6294a90a306a 2024-01-29 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc 2024-01-29 Warnings Exact identifier application number: M016 Cetaphil Baby Healing PETROLATUM Galderma Laboratories, L.P. 5140754e-5db0-470f-adfd-de02b184880b 2024-01-29 Warnings Exact identifier application number: M016 CHAPSTICK CLASSIC MEDICATED CAMPHOR, MENTHOL, PETROLATUM Haleon US Holdings LLC b4259621-ff41-46cc-a658-b57bff3c1525 2024-01-23 Warnings Exact identifier application number: M016 Zinc Oxide 20% ZINC OXIDE Trifecta Pharmaceuticals USA fcef17f1-84e7-a288-e053-6294a90a064b 2024-01-19 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