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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Perrigo Direct, Inc	e11470b2-80d6-4008-b87e-eb6aeadfce74	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Perrigo Direct, Inc	cc0378f2-6d5f-47ec-b16a-64668b4c29cc	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Meijer, Inc.	adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Meijer, Inc.	1b72f927-c2ae-4190-a035-5d7bb9f53c15	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Meijer, Inc.	af293cc0-ccd5-42a6-861b-c19fa6ffd06a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Meijer, Inc.	09878fe0-0890-4af3-a3f6-d2890041e9f8	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Meijer, Inc.	fa8ae34c-7b68-454f-8a3b-0eaa93a34092	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Diaper Rash	ZINC OXIDE	Meijer, Inc.	04bec667-a11e-42d2-a4b3-1416eebf1e8d	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Meijer, Inc.	8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Meijer, Inc.	75b91b97-ea84-4c4d-9e58-5a9ff27a778c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	d36a7479-7b3b-49fe-8144-b5cce0e173fb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTURIZING	Meijer, Inc.	44949b46-70f2-4e52-adba-a8455da614eb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Meijer, Inc.	13e4aece-5b91-4f89-a912-540bf170a8d1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Target Corporation	7fb5f9ca-cd90-4933-9fe8-907ece00458b	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Target Corporation	5237c7f2-7135-4558-a758-4fc2a232172f	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Target Corporation	3e620e4f-9e29-9e39-e063-6394a90adeda	2026-02-18	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