TCX Skincare

Product NDC: 49449-100
Requested package NDC: 49449-100-01
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 · 1 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 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 53 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZO Skin Health Post Procedure Program	ALUMINUM ACETATE	ZO Skin Health, Inc.	9786acc8-06ae-4f2b-9602-b7e8c3baeca5	2024-11-12	Warnings	Exact identifier application number: M016
DUKAL WHITE PETROLATUM	PETROLATUM	Dukal LLC	0c6474ed-2343-d5f2-e063-6394a90a30b3	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	2fead2d8-b645-4d45-8e5b-b4f1da4e5a25	2024-11-12	Warnings	Exact identifier application number: M016
CVS Health Advanced Scar Gel	ADVANCED SCAR GEL	CVS Health	c6926594-ad4e-4937-bda2-9311219a8881	2024-11-12	Warnings	Exact identifier application number: M016
CVS Zinc Oxide	ZINC OXIDE	CVS Health	d67533b1-ae3f-4c9a-a6c9-a742290c90e9	2024-11-11	Warnings	Exact identifier application number: M016
CVS Eczema Relief Skin Protectant	OATMEAL	CVS Health	3cf25c43-592f-41cb-aa0b-a82f4e7faf3d	2024-11-11	Warnings	Exact identifier application number: M016
DGH Advanced Formula Scar Skin Protectant	ALLANTOIN	Dolgencorp Inc	950dcffd-d2c3-4ca7-8a15-7cb1016ca364	2024-11-08	Warnings	Exact identifier application number: M016
ABC Arbonne Baby Care Diaper Rash	DIMETHICONE AND ZINC OXIDE	Arbonne International, LLC	dd1d8198-bb9d-4508-a971-ae3bc624cdd1	2024-11-08	Warnings	Exact identifier application number: M016
SUPER SENSITIVE DIAPER RASH	ZINC OXIDE	ORGANIC & SUSTAINABLE BEAUTY	b0de2a9b-7854-4caf-b7ff-632c1d4a382e	2024-11-08	Warnings	Exact identifier application number: M016
Dove	DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION	Conopco, Inc. d/b/a/ Unilever	bcfb12ea-304e-7d8c-e053-2a95a90af606	2024-11-07	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM	Conopco, Inc. d/b/a/ Unilever	bd206830-e334-3764-e053-2995a90a74ca	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR	Conopco Inc. d/b/a/ Unilever	b9e61a03-e000-50ab-e053-2a95a90a3210	2024-11-07	Warnings	Exact identifier application number: M016
Dove	DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f8cb31-560c-79e0-e053-2a95a90a39ae	2024-11-07	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL HAND WASH	Conopco Inc. d/b/a/ Unilever	ed234413-777a-9c82-e053-2a95a90a6f98	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	CATCHING THE SUNRISE HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b9fa6c72-7c56-6fd0-e053-2995a90a6707	2024-11-07	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	ed24b320-27fc-9714-e053-2995a90a79a6	2024-11-07	Warnings	Exact identifier application number: M016
SKINSEI	ETHYL ALCOHOL LIQUID	Conopco Inc. d/b/a/ Unilever	a603c419-238f-0bae-e053-2a95a90abc2b	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	UNDER THE STARLIT SKY HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0dfe52-c550-94fd-e053-2995a90a9800	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SUMMERTIME SPRINKLERS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0e474c-db62-910f-e053-2995a90a889e	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	GIRLS NIGHT OUT HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ce03e-5e7b-b09a-e053-2995a90a4eef	2024-11-07	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

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