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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c3be950b-28cf-47c2-9570-ebd46e43b1ba	Available on FDA.report

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
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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fc9eecd-fd25-827c-e063-6394a90a26a5	2025-03-26	Warnings	Exact identifier application number: M016
Cocoa Butter Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fcc9626-6058-e9b3-e063-6394a90ab525	2025-03-26	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	313b08e2-d764-96da-e063-6294a90ab705	2025-03-25	Warnings	Exact identifier application number: M016
Eczema Cream	ECZEMA CREAM	Kyte Baby LLC	30c943aa-d9dc-5c16-e063-6294a90a3c58	2025-03-20	Warnings	Exact identifier application number: M016
Koala Kubs Diaper Rash Cream	DIAPER RASH CREAM	Melaleuca, Inc.	c6b3b0dd-22a8-16f7-e053-2a95a90a51ea	2025-03-20	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant Cream	COLLOIDAL OATMEAL	Chattem, Inc.	2b6b8342-878d-4588-8b24-6746d35d319d	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b20bd5-3b4f-8cc7-e063-6394a90a9106	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b2744d-fb59-f383-e063-6294a90abd2a	2025-03-19	Warnings	Exact identifier application number: M016
Dr. Butler Hemorrhoid and Perineal	MINERAL OIL 59.8%,PETROLATUM 36%	Beyond Health P.A.	d17b6f16-6893-ce0a-e053-2a95a90aa23a	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream	DIMETHICONE, WHITE PETROLATUM	Chattem, Inc.	b951d1cb-b81e-4d7f-9a67-8405daa89667	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Hand Cream	COLLOIDAL OATMEAL	Chattem, Inc.	27457bc5-3edc-4c8b-b8a2-eaf09b511cf8	2025-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	30a977c3-6862-670e-e063-6294a90aeb2f	2025-03-18	Warnings	Exact identifier application number: M016
YVTYVT Copper Peptides Face Serum	COPPER TRIPEPTIDE-1	Beijing JUNGE Technology Co., Ltd.	306f2d48-43b8-359a-e063-6394a90a06dc	2025-03-16	Boxed warning, Warnings	Exact identifier application number: M016
Dr Talbots Cooling Perineal Pad	WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE	Talbot's Pharmaceuticals family Products, LLC.	242277e2-ff26-ad4e-e063-6394a90ab317	2025-03-14	Warnings	Exact identifier application number: M016
RID Poison Ivy Rash Relief	CALAMINE AND ZINC OXIDE	Oystershell Consumer Health Inc.	36c3af9a-2646-4427-e063-6394a90a2c5e	2025-03-13	Warnings	Exact identifier application number: M016
Aavini Double Layer Brightening Spot Correcting Essence Oil	AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL	Qingyuan Moksha Biotechnology Co., Ltd.	2ff89a13-3969-2df1-e063-6394a90ac0d3	2025-03-10	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3008bbeb-abba-5cdb-e063-6294a90ae483	2025-03-10	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2fc4745c-fac9-7861-e063-6294a90a3f14	2025-03-07	Warnings	Exact identifier application number: M016
AD Skin Protectant	AD SKIN PROTECTANT	WellSpring Pharmaceutical Corporation	d26f1312-2e1b-4106-bc48-a336d4e034ad	2025-03-07	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Nighttime Balm	OATMEAL	Kenvue Brands LLC	04d90e45-c2ee-4122-b919-a0eb6d11b59a	2025-03-04	Warnings	Exact identifier application number: M016

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1189915	colloidal oatmeal 2 % Topical Cream	PSN	c3be950b-28cf-47c2-9570-ebd46e43b1ba	6
1189915	colloidal oatmeal 20 MG/ML Topical Cream	SCD	c3be950b-28cf-47c2-9570-ebd46e43b1ba	6
1189915	colloidal oatmeal 2 % Topical Cream	SY	c3be950b-28cf-47c2-9570-ebd46e43b1ba	6

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tcx skincare ® Unique Hydromimetics ™	Theraceutix, LLC \| Fragrance Manufacturing, Inc.	2025-12-24	HUMAN OTC DRUG LABEL	6