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 1 of 70 · 1,388 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermaka Infants and Kids Multi Purpose Skin Protectant	ZINC OXIDE	Dermaka Skin Products LLC	f84dfd55-db6c-4d75-be67-4d13a139e209	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose	DIMETHICONE	L'Oreal USA Products Inc	805cd262-2689-4818-8fed-ddefacbdde23	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose	DIMETHICONE	Cosmetique Active Production	d19f482c-bec7-45aa-b22f-fe91a3dc717d	2026-09-10	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	CVS Pharmacy, Inc.	35e67726-4527-4cd7-8e73-30325a32402c	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	CVS Pharmacy, Inc.	606f65a8-08fd-4ab6-9d68-03ddf662bdf0	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Soothing Moisturizing Cream	COLLOIDAL OATMEAL	Nice-Pak Products, LLC	23548524-2e2e-4d1a-9ebb-6f86d6279e93	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walgreen Co.	22bd8e87-965c-466b-bb9b-7d4753e500bc	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. pharmacy Scar Cream	ALLANTOIN	OL PHARMA TECH, LLC Drs PHARMACY	d0381034-8cf7-5e8d-e053-2995a90a9faa	2026-09-09	Warnings	Exact identifier application number: M016
Drs. Pharmacy baby healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	5b14ffa0-9486-a7fe-e063-6394a90ab3ed	2026-09-09	Warnings	Exact identifier application number: M016
Wart Remover	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	5af3afe1-dad5-91b7-e063-6294a90ab95e	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb3595-f014-153e-e063-6294a90ad34b	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb59b4-491c-45bb-e063-6294a90a0ae6	2026-09-08	Warnings	Exact identifier application number: M016
Claravie	ALUMINUM HYDROXIDE GEL	Gentell LLC	5afea757-8feb-f907-e063-6394a90a6259	2026-09-08	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	United Natural Foods, Inc. dba UNFI	242adc68-f9e0-4f69-a580-a107d1634b50	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a9aaca8-474a-0393-e063-6394a90a5a3a	2026-09-04	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	5a7b0470-3ed5-5b92-e063-6294a90ae0f4	2026-09-03	Warnings	Exact identifier application number: M016
First Aid Beauty Face and Body Bestsellers Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a974dbf-84ac-5374-e063-6294a90a8da0	2026-09-03	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	Jell Pharmaceuticals Pvt. Ltd.	cdc297cb-476a-6da9-e053-2a95a90a399a	2026-09-02	Warnings	Exact identifier application number: M016
Nail Treatment Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5a7cd607-a50e-17d0-e063-6294a90acdb2	2026-09-02	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