Derma Breeze Skin Protectant Cream

Product NDC: 69475-5411
11-digit product format: 694755411
Labeler code: 69475
Product ID: 69475-5411_24fc11d4-5d8c-2f53-e054-00144ff8d46c
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal
Dosage form: CREAM
Route: TOPICAL
Labeler: Greyson International, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-09-15
Marketing end: 0000-00-00
Substance: OATMEAL
Active strength: 10 mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69475-5411		I	Inactivated by FDA	2026-10-05
excluded package	package	69475-5411	69475-5411-0	I	Inactivated by FDA	2026-10-05
excluded package	package	69475-5411	69475-5411-1	I	Inactivated by FDA	2026-10-05

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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69475-5411-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69475-5411-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69475-5411-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69475-5411-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69475-5411-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69475-5411-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69475-5411-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69475-5411-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69475-5411-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69475-5411-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69475-5411-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69475-5411-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69475-5411-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69475-5411-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69475-5411-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69475-5411-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69475-5411-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69475-5411-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69475-5411-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69475-5411-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69475-5411-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69475-5411-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69475-5411-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69475-5411-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69475-5411-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69475-5411-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69475-5411-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69475-5411-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69475-5411-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69475-5411-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69475-5411-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69475-5411-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69475-5411-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69475-5411-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69475-5411-0	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69475-5411-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69475-5411-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69475-5411-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69475-5411-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69475-5411-1	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69475-5411-0	2020-01-31	C162847	48780-1	9d75b9d1-0378-f424-e053-dadaa90a57ce	Derma Breeze 1% colloidal oatmeal with Trilexon
69475-5411-1	2020-01-31	C162847	48780-1	9d75b9d1-0378-f424-e053-dadaa90a57ce	Derma Breeze 1% colloidal oatmeal with Trilexon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69475-5411-0	Derma Breeze Skin Protectant Cream	28.35 g in 1 TUBE	CREAM	28.35		3
69475-5411-1	Derma Breeze Skin Protectant Cream	1000 g in 1 CONTAINER	CREAM	1000		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
OATMEAL	ACTIVE MOIETY	8PI54V663Y	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
CURDLAN	INACTIVE INGREDIENT	6930DL209R	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
ISOCETYL STEARATE	INACTIVE INGREDIENT	3RJ7186O9W	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
PEG-10 SOY STEROL	INACTIVE INGREDIENT	FG54K98L0Q	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
PPG-51/SMDI COPOLYMER	INACTIVE INGREDIENT	KQ9JG3O3YA	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
PROPYLENE GLYCOL STEARATE	INACTIVE INGREDIENT	MZM1I680W0	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
SACCHARIDE ISOMERATE	INACTIVE INGREDIENT	W8K377W98I	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69475-5411	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3	Legacy NDC, 2 package rows	20151120_24736c38-1b5c-6514-e054-00144ff8d46c.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
240651	colloidal oatmeal 1 % Topical Cream	PSN	24736c38-1b5c-6514-e054-00144ff8d46c	3
240651	colloidal oatmeal 10 MG/ML Topical Cream	SCD	24736c38-1b5c-6514-e054-00144ff8d46c	3
240651	Avena sativa 1 % Topical Cream	SY	24736c38-1b5c-6514-e054-00144ff8d46c	3
240651	colloidal oatmeal 1 % Topical Cream	SY	24736c38-1b5c-6514-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69475-5411-0	69475541100	28.35 g in 1 TUBE	28.35 g	Historical
69475-5411-1	69475541101	1000 g in 1 CONTAINER	1000 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Derma Breeze 1% colloidal oatmeal with Trilexon	Greyson International, Inc.	2015-11-20	HUMAN OTC DRUG LABEL	3