IMAGE ESSENTIALS

Product NDC: 49738-320
11-digit product format: 497380320
Labeler code: 49738
Product ID: 49738-320_ecc34f8e-3746-49fa-a086-e7c8f6eaec1f
Type: HUMAN OTC DRUG
Nonproprietary name: DIMETHICONE
Dosage form: LOTION
Route: TOPICAL
Labeler: KMART CORPORATION
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-02-25
Marketing end: 0000-00-00
Substance: DIMETHICONE
Active strength: 13 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49738-320		I	Inactivated by FDA		2026-08-17
excluded package	package	49738-320	49738-320-18	I	Inactivated by FDA		2026-08-17

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 · 42 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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`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	49738-320-18	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49738-320-18	`9bebd1f3094a…`	`5416666fcb17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49738-320-18	2020-01-31	C162847	48780-1	9d75b9d0-1ea0-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49738-320-18	IMAGE ESSENTIALSOATMEAL MOISTURIZING	532 mL in 1 BOTTLE, PLASTIC	LOTION	532		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
OATMEAL	INACTIVE INGREDIENT	8PI54V663Y	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49738-320	IMAGE ESSENTIALS OATMEAL MOISTURIZING (DIMETHICONE) LOTION [KMART CORPORATION]	1	Legacy NDC, 1 package rows	20140227_be6d953e-d4aa-407c-932c-af7a3b18a980.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000636	dimethicone 1.25 % Topical Lotion	PSN	be6d953e-d4aa-407c-932c-af7a3b18a980	1
1000636	dimethicone 12.5 MG/ML Topical Lotion	SCD	be6d953e-d4aa-407c-932c-af7a3b18a980	1
1000636	dimethicone 1.25 % Topical Lotion	SY	be6d953e-d4aa-407c-932c-af7a3b18a980	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49738-320-18	49738032018	532 mL in 1 BOTTLE, PLASTIC	532 ml	Historical