Pediadermics eczema 3

Product NDC: 76348-580
11-digit product format: 763480580
Labeler code: 76348
Product ID: 76348-580_44fe1bad-8844-9960-e063-6394a90a8a7a
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal, Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-10-01
Substance: DIMETHICONE; OATMEAL
Active strength: 3.36; .168 g/168g; g/168g
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], Skin Barrier Activity [PE]
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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76348-580-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76348-580-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76348-580-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-580-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-580-06	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-580-06	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-580-06	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Pediadermics eczema 3
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	3.36 g/168g
OATMEAL	.168 g/168g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup
8PI54V663Y	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
af861f0b-4387-6861-e053-2995a90a8bfa	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-580-06	2025-04-18	C162847	48780-1	2cef2736-6a81-d83d-e063-dadaa90ab31f	Pediadermics eczema 3
76348-580-06	2025-01-30	C162847	48780-1	2cef2736-6a81-d83d-e063-dadaa90ab31f	Pediadermics eczema 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-580-06	Pediadermics eczema 3	168 g in 1 TUBE	CREAM	168		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-580	PEDIADERMICS ECZEMA 3 (COLLOIDAL OATMEAL, DIMETHICONE) CREAM [RENU LABORATORIES, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20250419_af861f0b-4387-6861-e053-2995a90a8bfa.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 24 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERADEX-E	PETROLATUM AND LANOLIN	ABBE Laboratories, Inc.	00100102-c245-4b63-a4ff-794cacda6f17	2026-01-24	Warnings	Exact identifier application number: M016
Hydrocortisone	DRS. HYDROCORTISONE	OL PHARMA TECH,LLC	b0eac8f3-bb80-6563-e053-2995a90a83c9	2026-01-22	Warnings	Exact identifier application number: M016
Eczema Reliegf Skin Protectant EQB	COLLOIDAL OATMEAL 2%	Walmart	37132a0d-37c5-4b21-9673-5f853b3a6248	2026-01-20	Warnings	Exact identifier application number: M016
Skin Relief Cream	HYDROCORTISONE	Spa de Soleil	0a90b77a-4be4-71c5-e063-6294a90a8e41	2026-01-20	Warnings	Exact identifier application number: M016
Cold Sore Bandage	COLD SORE BANDAGE	Shenzhen Hengdasheng Technology Co., Ltd	47f588a2-a69b-cffe-e063-6294a90a0ed4	2026-01-17	Warnings	Exact identifier application number: M016
Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	48793a50-89a7-dba9-e063-6394a90a7056	2026-01-16	Warnings	Exact identifier application number: M016
HAND SANITIZER	HAND SANITIZER	Guangdong bangze medicine co., ltd	40018618-8f95-f6db-e063-6394a90ac7dd	2026-01-16	Warnings	Exact identifier application number: M016
Lemon Glycerin	GLYCERIN	Jianerkang Medical Co., Ltd	edee14da-13d8-4bc2-9c37-cfc353763d11	2026-01-16	Warnings	Exact identifier application number: M016
WORKMANS FRIEND SUPERIOR BARRIER SKIN	DIMETHICONE	SolvChem, Inc.	da12ac2c-1af9-47b1-aa5f-77acb48535ba	2026-01-16	Warnings	Exact identifier application number: M016
Walgreens Vitamin A and D skin protectant	LANOLIN, PETROLATUM	Walgreen Company	9aa6c7f2-0923-4d51-8b9b-63f9a724937a	2026-01-15	Warnings	Exact identifier application number: M016
INCONTINENCE CARE WIPE	DIMETHICONE	Cardinal Health 200, Inc.	1ac34c94-9e3b-45f2-ba19-a07dcd3941dd	2026-01-15	Warnings	Exact identifier application number: M016
Alcohol Hand Sanitizer	ALCOHOL HAND SANITIZER	Guangdong bangze medicine co., ltd	2e8b5afe-6ff8-3e9b-e063-6394a90ad703	2026-01-14	Warnings	Exact identifier application number: M016
Alcohol Sanitizer	ALCOHOL SANITIZER SPRAY	Guangdong bangze medicine co., ltd	2e9db49b-35ce-00d5-e063-6294a90acf35	2026-01-14	Warnings	Exact identifier application number: M016
GG XEROZINE 15	SKIN PROTECTANT	GERI-GENTLE CORPORATION	e6881c6d-f584-26d0-e053-2995a90a3873	2026-01-14	Warnings	Exact identifier application number: M016
Medpura Zinc Oxide 20%	MEDPURA ZINC OXIDE 20%	Akron Pharma Inc.	3a63aaea-087e-4115-8478-64d416e6085f	2026-01-14	Warnings	Exact identifier application number: M016
Walgreens Baby Petroleum	PETROLATUM	Walgreen Company	e79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d	2026-01-14	Warnings	Exact identifier application number: M016
Walgreens Cocoa Butter Jelly	PETROLEUM	Walgreens	32b84286-471a-4d15-80fb-2f516dc1d6ea	2026-01-14	Warnings	Exact identifier application number: M016
Hydrating Healing Skin Protectant	PETROLATUM OINTMENT	CVS Pharmacy	c129c2b0-10d5-4b5d-ac5c-2e2512e61279	2026-01-14	Warnings	Exact identifier application number: M016
Multi-Purpose Skin Protectant	A AND D OINTMENT	CVS Pharmacy	60bd0095-25d3-44af-9502-0c63b3d25e66	2026-01-14	Warnings	Exact identifier application number: M016
Kenkoderm Eczema Honey Intensive Soothing Balm	KENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALM	Guangzhou Ariel Biotech Co., Ltd.	48652b9c-4063-cc16-e063-6394a90a3b86	2026-01-14	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
8PI54V663Y	OATMEAL		OATMEAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-580-06	76348058006	168 g in 1 TUBE (76348-580-06)	168 g	2020-10-01	0000-00-00	No	No	Current