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 43 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fc9eecd-fd25-827c-e063-6394a90a26a5	2025-03-26	Warnings	Exact identifier application number: M016
Cocoa Butter Petroleum Jelly	WHITE PETROLATUM JELLY	WALGREENS	1fcc9626-6058-e9b3-e063-6394a90ab525	2025-03-26	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	313b08e2-d764-96da-e063-6294a90ab705	2025-03-25	Warnings	Exact identifier application number: M016
Eczema Cream	ECZEMA CREAM	Kyte Baby LLC	30c943aa-d9dc-5c16-e063-6294a90a3c58	2025-03-20	Warnings	Exact identifier application number: M016
Koala Kubs Diaper Rash Cream	DIAPER RASH CREAM	Melaleuca, Inc.	c6b3b0dd-22a8-16f7-e053-2a95a90a51ea	2025-03-20	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Skin Protectant Cream	COLLOIDAL OATMEAL	Chattem, Inc.	2b6b8342-878d-4588-8b24-6746d35d319d	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b20bd5-3b4f-8cc7-e063-6394a90a9106	2025-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	30b2744d-fb59-f383-e063-6294a90abd2a	2025-03-19	Warnings	Exact identifier application number: M016
Dr. Butler Hemorrhoid and Perineal	MINERAL OIL 59.8%,PETROLATUM 36%	Beyond Health P.A.	d17b6f16-6893-ce0a-e053-2a95a90aa23a	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream	DIMETHICONE, WHITE PETROLATUM	Chattem, Inc.	b951d1cb-b81e-4d7f-9a67-8405daa89667	2025-03-19	Warnings	Exact identifier application number: M016
Gold Bond Eczema Relief Medicated Hand Cream	COLLOIDAL OATMEAL	Chattem, Inc.	27457bc5-3edc-4c8b-b8a2-eaf09b511cf8	2025-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	30a977c3-6862-670e-e063-6294a90aeb2f	2025-03-18	Warnings	Exact identifier application number: M016
YVTYVT Copper Peptides Face Serum	COPPER TRIPEPTIDE-1	Beijing JUNGE Technology Co., Ltd.	306f2d48-43b8-359a-e063-6394a90a06dc	2025-03-16	Boxed warning, Warnings	Exact identifier application number: M016
Dr Talbots Cooling Perineal Pad	WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE	Talbot's Pharmaceuticals family Products, LLC.	242277e2-ff26-ad4e-e063-6394a90ab317	2025-03-14	Warnings	Exact identifier application number: M016
RID Poison Ivy Rash Relief	CALAMINE AND ZINC OXIDE	Oystershell Consumer Health Inc.	36c3af9a-2646-4427-e063-6394a90a2c5e	2025-03-13	Warnings	Exact identifier application number: M016
Aavini Double Layer Brightening Spot Correcting Essence Oil	AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL	Qingyuan Moksha Biotechnology Co., Ltd.	2ff89a13-3969-2df1-e063-6394a90ac0d3	2025-03-10	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3008bbeb-abba-5cdb-e063-6294a90ae483	2025-03-10	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2fc4745c-fac9-7861-e063-6294a90a3f14	2025-03-07	Warnings	Exact identifier application number: M016
AD Skin Protectant	AD SKIN PROTECTANT	WellSpring Pharmaceutical Corporation	d26f1312-2e1b-4106-bc48-a336d4e034ad	2025-03-07	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Nighttime Balm	OATMEAL	Kenvue Brands LLC	04d90e45-c2ee-4122-b919-a0eb6d11b59a	2025-03-04	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