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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	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