Skin Protectant

Product NDC: 69123-111
11-digit product format: 691230111
Labeler code: 69123
Product ID: 69123-111_7d1c93bb-808e-4e8d-9670-af940f07a4bc
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ELAJ, LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-07-25
Marketing end: 0000-00-00
Substance: OATMEAL
Active strength: 1 g/57g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69123-111		I	Inactivated by FDA	2026-10-05
excluded package	package	69123-111	69123-111-01	I	Inactivated by FDA	2026-10-05
excluded package	package	69123-111	69123-111-02	I	Inactivated by FDA	2026-10-05
excluded package	package	69123-111	69123-111-03	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 · 88 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	69123-111-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69123-111-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69123-111-02	`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	69123-111-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69123-111-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69123-111-02	`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	69123-111-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69123-111-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69123-111-02	`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	69123-111-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69123-111-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69123-111-02	`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	69123-111-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69123-111-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69123-111-02	`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	69123-111-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69123-111-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69123-111-02	`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	69123-111-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69123-111-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69123-111-02	`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	69123-111-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69123-111-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69123-111-02	`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	69123-111-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69123-111-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69123-111-02	`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	69123-111-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69123-111-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69123-111-02	`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	69123-111-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69123-111-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69123-111-02	`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	69123-111-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69123-111-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69123-111-02	`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	69123-111-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69123-111-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69123-111-02	`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	69123-111-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69123-111-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69123-111-02	`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	69123-111-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69123-111-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69123-111-02	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69123-111-01	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT
69123-111-02	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT
69123-111-03	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69123-111-01	Skin Protectant	1 in 1 BOX	OINTMENT	1	1
69123-111-01	Skin Protectant	57 g in 1 CONTAINER	OINTMENT	57	1
69123-111-02	Skin Protectant	1 in 1 BOX	OINTMENT	1	1
69123-111-02	Skin Protectant	113 g in 1 CONTAINER	OINTMENT	113	1
69123-111-03	Skin Protectant	227 g in 1 CONTAINER	OINTMENT	227	1
69123-111-03	Skin Protectant	1 in 1 BOX	OINTMENT	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
OATMEAL	ACTIVE MOIETY	8PI54V663Y	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
Vanilla	INACTIVE INGREDIENT	Q74T35078H	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69123-111	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1	Legacy NDC, 6 package rows	20140812_6537167b-4f8a-485e-bf20-b23d55d5437c.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
1545142	colloidal oatmeal 1 % Topical Ointment	PSN	6537167b-4f8a-485e-bf20-b23d55d5437c	1
1545142	colloidal oatmeal 0.01 MG/MG Topical Ointment	SCD	6537167b-4f8a-485e-bf20-b23d55d5437c	1
1545142	colloidal oatmeal 1 % Topical Ointment	SY	6537167b-4f8a-485e-bf20-b23d55d5437c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69123-111-01	69123011101	1 in 1 BOX		Historical
69123-111-02	69123011102	1 in 1 BOX		Historical
69123-111-03	69123011103	227 g in 1 CONTAINER	227 g	Historical