ECZEMA DERMATITIS RELIEF BALM

Product NDC: 61328-112
11-digit product format: 613280112
Labeler code: 61328
Product ID: 61328-112_5b4ad054-9ed9-c5f3-e063-6294a90a0d33
Type: HUMAN OTC DRUG
Nonproprietary name: COLLOIDAL OATMEAL
Dosage form: CREAM
Route: TOPICAL
Labeler: Skinfix, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-01
Substance: OATMEAL
Active strength: 5 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: 2027-12-31
Current FDA listing: Yes

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: ECZEMA DERMATITIS RELIEF BALM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OATMEAL	5 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
124351b2-6dbf-42d0-9ea7-f0e299215f9a	Product name	1	20210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61328-112-20	ECZEMA DERMATITIS RELIEF BALM	50 g in 1 BOTTLE, PUMP	CREAM	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61328-112	ECZEMA DERMATITIS RELIEF BALM (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]	2	Current NDC, 1 package rows	20241228_fb801d20-9bec-1c71-e053-6394a90a6e95.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 7 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sosnowskis Magic Healing Multi action	CAMPHOR AND COLLOIDAL OATMEAL	Herstat (USA) Inc.	38cd8f11-7264-a004-e063-6294a90a3a1b	2026-07-03	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Publix Super Markets, Inc.	c94b5574-3fd7-48a8-94ef-db5d7184fa10	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. Pharmacy Baby Healing	ZINC OXIDE	OL PHARMA TECH, LLC Drs PHARMACY	55a6981c-1b32-f448-e063-6294a90ac6d8	2026-07-02	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	558d239e-b0cf-c145-e063-6294a90a8a8b	2026-07-01	Warnings	Exact identifier application number: M016
DIMETHICONE SKIN PROTECTANT	DIMETHICONE	VIVE HEALTH LLC	5591a321-4831-1844-e063-6394a90a12d1	2026-07-01	Warnings	Exact identifier application number: M016
Drs. Pharmacy healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	55947cd9-ca25-0844-e063-6294a90a381f	2026-07-01	Warnings	Exact identifier application number: M016
AVANCE ALOE INCONTINENCE CARE	DIMETICONE	SMART CHOICE MEDICAL INC.	55833e0f-d184-16a2-e063-6394a90acfd3	2026-06-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55664a0f-7d46-f002-e063-6394a90a2dc7	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5566bce3-fc49-5ef4-e063-6294a90abc7a	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5568ada5-3ae6-3366-e063-6294a90a7119	2026-06-29	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	55698d88-aae7-c46c-e063-6394a90ad0ac	2026-06-29	Warnings	Exact identifier application number: M016
Earth Baby Diaper Rash Cream	ZINC OXIDE	Earth Baby, Inc	42c5cf9a-0a35-5681-e054-00144ff8d46c	2026-06-28	Warnings	Exact identifier application number: M016
ORLASKIN HYDROGEL EYE MASK	ALLANTOIN	Guangzhou Yapheon Health Industry Co., Ltd.	552d072b-396f-c88a-e063-6294a90aabcd	2026-06-26	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM	Medline Industries, LP	3c442890-733d-8175-e063-6294a90a8b1c	2026-06-24	Warnings	Exact identifier application number: M016
MOROVAN	ESTRIOL	HONG KONG UNORDERED TRADING CO., LIMITED	54fa4308-44a4-e9dd-e063-6394a90a0cd7	2026-06-24	Warnings	Exact identifier application number: M016
EELHOE Sleep Aid Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	550b0494-ca6d-c897-e063-6394a90a8751	2026-06-24	Warnings	Exact identifier application number: M016
Hair Regrowth Liquid	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	54e662e7-9c63-ad6b-e063-6294a90a1b8d	2026-06-23	Warnings	Exact identifier application number: M016
RoyceDerm Eczema Relief Body Wash	COLLOIDAL OATMEAL 2%	RoyceDerm LLC	54e74eb4-1b42-a748-e063-6394a90aeb16	2026-06-23	Warnings	Exact identifier application number: M016
Comfort Shield Barrier	DIMETHICONE	Sage Products LLC	cc08f571-84ae-4c2f-b09d-a83a8efc39f5	2026-06-23	Warnings	Exact identifier application number: M016
CLEAR ANTI ITCH	PRAMOXINE HCL, ZINC ACETATE LOTION	H E B	54f04056-d805-8c62-e063-6394a90ab740	2026-06-23	Warnings, Adverse reactions	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
1595494	colloidal oatmeal 5 % Topical Cream	PSN	fb801d20-9bec-1c71-e053-6394a90a6e95	4
1595494	colloidal oatmeal 50 MG/ML Topical Cream	SCD	fb801d20-9bec-1c71-e053-6394a90a6e95	4
1595494	colloidal oatmeal 5 % Topical Cream	SY	fb801d20-9bec-1c71-e053-6394a90a6e95	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61328-112-20	61328011220	50 g in 1 BOTTLE, PUMP (61328-112-20)	50 g	2023-10-01	No	No	Current
61328-112-30	61328011230	1 TUBE in 1 CARTON (61328-112-30) / 40 g in 1 TUBE	1 tube	2026-09-12	No	No	Current