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 21 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daily Moisturizing	DIMETHICONE	Topco Associates LLC	47e54eee-70e0-4bfa-ae77-d61a6560a9e1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Topco Associates LLC	471a9f8d-ba12-41d3-a510-20c1a13ff850	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Wakefern Food Corp.	b799229b-f7ca-494c-afde-1fd096aef66e	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	WinCo Foods, LLC	659cc8c7-6300-41c0-a684-c5fde7f2b100	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Walgreen Co.	220f70e1-0802-4fe2-92d0-78dec557c993	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Walgreen Co.	417ae199-54bb-420f-a3cf-1c096062d78c	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
First Aid Beauty Dry Skin Rescue Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4a93d029-d721-0bb5-e063-6294a90a17c4	2026-02-11	Warnings	Exact identifier application number: M016
Natouch Eczema Wipes	ECZEMA WIPES	Natouch LLC	0a9756a4-2fa9-cd19-e063-6294a90a93ad	2026-02-10	Warnings	Exact identifier application number: M016
EARTHS CARE Eczema Cream	ECZEMA	DLC Laboratories, Inc.	17436fa0-d6c7-1052-e063-6294a90adae4	2026-02-09	Warnings	Exact identifier application number: M016
Petrolatum	WHITE PETROLATUM	Retail Business Services, LLC	bf0c9494-0138-4346-9348-e235ca4d9e58	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Retail Business Services, LLC	a80b8fee-2dd9-4640-a4f8-4cf940df8563	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Retail Business Services, LLC	6e9121c8-5eb9-4d0b-86c5-b892e14bdab8	2026-02-06	Warnings	Exact identifier application number: M016
Petrolatum	WHITE PETROLATUM	Retail Business Services, LLC	bf73c618-ed2f-4468-a51f-ff61c7b1f506	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Retail Business Services, LLC	c8a876e2-0a34-4c3d-a0bc-549dd3048e8a	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Salado Sales Inc.	f973e3a5-3b45-4842-99ce-dff676ae1f96	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Pharmacy Value Alliance, LLC	0ce03cd1-c48d-45cf-b11f-08bade55dcb6	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Publix Super Markets, Inc.	28ac9de4-2a63-4839-bed5-9bcc59ebeb2a	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Publix Super Markets, Inc.	0098c983-c518-4a14-8635-c7bdde7bff4f	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M016
TN Dickinsons Pain and Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Dickinson Brands Inc.	537c9c27-ee81-4920-8e3f-21edb844c9cf	2026-02-05	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Nighttime Itch Relief Balm	COLLOIDAL OATMEAL	Kenvue Brands LLC	e3350a8f-b983-7c4d-e053-2a95a90a53f5	2026-02-04	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