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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	4a43b1a2-2156-e490-e063-6294a90a6f84	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE 8%, ZINC OXIDE 8%	Farmacias De Similares TX LLC	4ecd0add-11c9-cf3b-e063-6394a90adff6	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	CVS Pharmacy, Inc.	4dc08832-e610-4e62-a6af-cadaa339e39e	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL SPRAY	CVS Pharmacy	53db78a8-eb2d-431b-84c1-73e99bb9d3d1	2026-04-06	Warnings	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Amazon.com Services LLC	616ef87d-1518-46aa-8e12-9a1b678d4980	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M016
Stabilizing Repair Serum	OATMEAL	Dermalogica, LLC.	86b7b230-5424-46d3-8058-656f5172fc70	2026-04-02	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	STRATEGIC SOURCING SERVICES	4e6a7bdf-4ef1-65e2-e063-6394a90ae124	2026-04-01	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	4e4e1797-26e6-a67b-e063-6294a90af438	2026-03-31	Warnings	Exact identifier application number: M016
Target Advanced Scar Gel	ADVANCED SCAR GEL	Target Corporation	86c215fe-aad4-45d1-bdb7-cde00a115c5c	2026-03-31	Warnings	Exact identifier application number: M016
Zinc oxide, Dimethicone	ZINC OXIDE, DIMETHICONE	Walmart Inc.	4cbf9492-33cd-e6d4-e063-6294a90ab001	2026-03-31	Warnings, Adverse reactions	Exact identifier application number: M016
Critic-Aid Clear	PETROLATUM	Coloplast Corp	a92c18f7-52b2-43e4-bae3-2bab9de22671	2026-03-31	Warnings	Exact identifier application number: M016
3M Cavilon Durable Barrier	DIMETHICONE	Solventum US LLC	f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83	2026-03-31	Warnings	Exact identifier application number: M016
XIMONTH Foot Sanitizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	4e38d24d-3745-c121-e063-6394a90abbb5	2026-03-30	Warnings	Exact identifier application number: M016
Dynashield	ZINC OXIDE	Dynarex Corporation	59fd865c-b81d-43ad-8fa0-c37ca0557769	2026-03-30	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant	COLLOIDAL OATMEAL	Port Jervis Laboratories, Inc	4e43b65c-d5bb-f228-e063-6294a90ad08d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4275956d-275a-4e31-e063-6394a90a78d3	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Cherry	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42762471-e5cd-505e-e063-6294a90afb7d	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Variety Cherry-Strawberry-Spearmint	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	450e46d2-de86-e5fa-e063-6294a90ac6ff	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	4512220a-9fc2-8816-e063-6394a90a9d15	2026-03-30	Warnings	Exact identifier application number: M016
ChapStick Classic Original Military	SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	45136b7e-136b-0283-e063-6394a90a599a	2026-03-30	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