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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	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