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 16 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Beauty FAB Ultra Repair Body Skin Protectant	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	1a9d86fc-ef32-baed-e063-6394a90a7d74	2026-03-12	Warnings	Exact identifier application number: M016
Meijer Scar Gel	ALLANTOIN 0.5%	Meijer	4c108c34-72f3-1382-e063-6394a90a7f2c	2026-03-11	Warnings	Exact identifier application number: M016
E2 hand wash	E2 SANITIZING HAND SOAP	Horizon Tool Inc.	a40afa46-a07d-f864-e053-2a95a90aef8a	2026-03-11	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4576cd28-9530-4db4-e063-6394a90a9fd3	2026-03-10	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Lidl US, LLC	e399b33f-5f7c-47eb-8e9b-1721ae4680b5	2026-03-10	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	WHITE PETROLATUM	Sion Biotext Medical Ltd.	503c4ab9-1f60-48e2-af47-7ef996466a5b	2026-03-09	Warnings	Exact identifier application number: M016
Trstay	RETINOL SERUM	Shenzhen yuehaotong Technology Co.,Ltd	4c6e20dd-0a71-a96b-e063-6294a90ab833	2026-03-07	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c7f645-cfb3-6db1-e063-6394a90a42ff	2026-03-06	Warnings	Exact identifier application number: M016
2-Pack Facial Serum	2-PACK FACIAL SERUM	Guangzhou Ariel Biotech Co., Ltd.	27c89fc6-016b-d359-e063-6394a90a5602	2026-03-06	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a	2026-03-06	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant	DIMETHICONE	The Procter & Gamble Manufacturing Company	276c68d4-e273-4e48-e063-6294a90ab16f	2026-03-04	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4c1d00b3-313b-933f-e063-6294a90ac46f	2026-03-03	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Amazon.com Services LLC	495fffd7-7b64-954a-e063-6394a90a81fd	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Amazon.com Services LLC	aceb0b10-8c90-4a06-8c47-cd1a2b4676a3	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Amazon.com Services LLC	134e07a1-5236-4088-baf9-1ff33126f793	2026-03-03	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Old East Main Co.	7f56ab98-dbd8-412a-8c31-bb6302b7f329	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Old East Main Co.	c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Old East Main Co.	ae8583c0-1b52-461d-8506-ec7524f1b4c4	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Old East Main Co.	aa1acc24-56af-4708-bf76-23d4de3d089e	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Old East Main Co.	de8d8071-ecb2-4719-8c7b-7944f27810d6	2026-03-02	Warnings, Adverse reactions	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