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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediadermics eczema 3	COLLOIDAL OATMEAL, DIMETHICONE	Renu Laboratories, LLC	af861f0b-4387-6861-e053-2995a90a8bfa	2025-12-02	Warnings	Exact identifier application number: M016 ndc (product): 76348-580
Flexitol Face and Eyelid Eczema	OATMEAL	LaCorium Health USA Inc.	f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65	2025-12-02	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 41%	Twin Med LLC	3d36e664-ac10-72eb-e063-6294a90a49c4	2025-12-01	Warnings	Exact identifier application number: M016
ProCure Vitamin A and D	WHITE PETROLATUM 93.4%	Twin Med LLC	3d385a07-2a12-fce7-e063-6294a90a32d6	2025-12-01	Warnings	Exact identifier application number: M016
ESTRIOL	ESTRIOL	Shenzhen Mengyue Technology Co., Ltd.	44de9eb4-080e-bfbc-e063-6394a90ac0ea	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Petroleum Jelly	PETROLATUM	New World Imports, Inc	e13fea4e-bd6d-425a-aa7e-1d41dc36bf00	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Cocoa Butter Petroleum Jelly	PETROLATUM	New World Imports, Inc	9358b8ef-df14-45fc-9bfd-9052577a1f88	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Zinc Oxide	ZINC OXIDE	New World Imports Inc	aa9ae4d1-4229-4894-9eaf-8588b2867472	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Petroleum	PETROLATUM	New World Imports, Inc	47e999de-08bd-4121-b6d0-270cc603b56d	2025-12-01	Warnings	Exact identifier application number: M016
HOEGOA Growth Hair Serum	GLYCERIN	Shantou Oralhoe Biotechnology Co., Ltd.	44b6609f-c58b-b6ac-e063-6394a90a749b	2025-11-29	Warnings	Exact identifier application number: M016
OUHOE Micro Darts Tag gone Patch	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	33ce447c-facd-35fb-e063-6394a90a1ead	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Herbal Hair Oil	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	30c3df30-e0c6-4efa-e063-6294a90ac40a	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Aloe Soothing Sun Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	326781e0-55dc-80fc-e063-6394a90a09aa	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Ultra Anti-Acne Control Gel	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3bd1b734-76b0-5264-e063-6294a90a32d0	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Lipoma Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3cb4aed1-3b13-a62a-e063-6294a90a6c39	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Para Crescimento	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	42fbfcac-29ab-51f7-e063-6394a90a626f	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Biotin With Hydrolyzed Collagen	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	43138915-5fe1-6e32-e063-6294a90abefa	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Pain Relief Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3f835843-eb04-6273-e063-6294a90ab2f0	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Skin Tag Remover	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	32922508-74ae-8347-e063-6294a90a6154	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Bodyacne Removal Cleanser	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3bbebf1d-2e22-1427-e063-6294a90a7999	2025-11-27	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