Secura Dimethicone Protectant

Product NDC: 69740-322
11-digit product format: 697400322
Labeler code: 69740
Product ID: 69740-322_29664526-07fd-f58e-e063-6294a90adde2
Type: HUMAN OTC DRUG
Nonproprietary name: DIMETHICONE
Dosage form: CREAM
Route: TOPICAL
Labeler: Smith & Nephew Medical Ltd
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-08-01
Substance: DIMETHICONE
Active strength: 50 mg/g
Pharmacologic classes: Skin Barrier Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69740-322	69740-322-01	D	Discontinued by firm		2026-10-12

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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69740-322-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69740-322-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69740-322-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69740-322-00	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69740-322-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69740-322-00	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69740-322-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69740-322-00	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69740-322-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69740-322-00	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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: Secura Dimethicone Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMETHICONE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259090	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
83f92ac9-4114-4192-926d-be2854a84106	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69740-322-00	2024-08-20	Secura Dimethicone Protectant
69740-322-01	2024-08-20	Secura Dimethicone Protectant
69740-322-00	2023-01-30	Secura Dimethicone Protectant
69740-322-01	2023-01-30	Secura Dimethicone Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69740-322-00	Secura Dimethicone Protectant	114 g in 1 TUBE	CREAM	114		10
69740-322-01	Secura Dimethicone Protectant	3.5 g in 1 PACKET	CREAM	3.5		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69740-322-00	GM - Gram	69740-322	0d4d9c45-cef4-4169-9c68-d771aa2facc3	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69740-322	SECURA DIMETHICONE PROTECTANT (DIMETHICONE) CREAM [SMITH & NEPHEW MEDICAL LTD]	10	Current NDC, Legacy NDC, 2 package rows	20241218_83f92ac9-4114-4192-926d-be2854a84106.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 15 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Softlips Peppermint Swirl	DIMETHICONE	The Mentholatum Company	4dbea50e-d82d-c702-e063-6394a90ac6e4	2026-03-24	Warnings	Exact identifier application number: M016
Softlips Vanilla	DIMETHICONE	The Mentholatum Company	56551008-a4e0-406f-8403-980d2e6b75a0	2026-03-24	Warnings	Exact identifier application number: M016
Selan Plus Zinc Oxide	SELAN PLUS ZINC OXIDE	Trividia Manufacturing Solutions, Inc	07396c61-1dfd-4be7-bddf-0eb570a18463	2026-03-24	Warnings	Exact identifier application number: M016
D-Cerin	MOISTURIZER	Dynarex Corporation	7ea47a7e-12af-9290-e053-2a91aa0a065f	2026-03-24	Warnings	Exact identifier application number: M016
MG217 Eczema Body	COLLOIDAL OATMEAL	Wisconsin Pharmacal Company	5f0cfd0c-ae87-f411-e053-2a91aa0ac251	2026-03-20	Warnings	Exact identifier application number: M016
Advanced Formula Scar Defense Cream	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d5c70f9-da41-b535-e063-6294a90a73f2	2026-03-19	Warnings	Exact identifier application number: M016
TriplePaste Adult Care Rash Treatment	ZINC OXIDE	Advantice Health, LLC	2cf0575c-8d3d-1f16-e063-6294a90a629d	2026-03-19	Warnings	Exact identifier application number: M016
multipurpose	ZINC OXIDE SKIN PROTECTANT	Advantice Health, LLC	291563cc-7491-ce41-e063-6394a90ac6c1	2026-03-19	Warnings	Exact identifier application number: M016
Triple Diaper Rash	ZINC OXIDE	Advantice Health, LLC	d457c58d-8239-41c4-999e-d0ba237e3945	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	f4464fb2-ba25-16f2-e053-2a95a90a0406	2026-03-19	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	fea4e5c7-780c-c7f4-e053-6294a90abb39	2026-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d46110b-5aa7-5261-e063-6394a90a423a	2026-03-18	Warnings	Exact identifier application number: M016
Advanced Bed Sore Wound Healing	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	4d589c18-e597-355a-e063-6394a90a4243	2026-03-18	Warnings	Exact identifier application number: M016
MediChoice Barrier	DIMETHICONE	O&M HALYARD, INC.	115c2a2f-d68a-316a-e063-6394a90a2716	2026-03-17	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	4d4427b0-25c3-ddf6-e063-6394a90a6153	2026-03-17	Warnings	Exact identifier application number: M016
Colloidal Oatmeal	COLLOIDAL OATMEAL	Walmart Inc.	4a93f77d-41dc-3bab-e063-6394a90a804b	2026-03-16	Warnings, Adverse reactions	Exact identifier application number: M016
Vaseline	HEALING JELLY	Conopco Inc. d/b/a Unilever	bd4418b7-c6aa-5e71-e053-2995a90a4cc4	2026-03-16	Warnings	Exact identifier application number: M016
Vaseline Intensive Care Deep Moisture	PETROLEUM	Conopco Inc. d/b/a Unilever	65cec560-25c7-4076-a33d-a3dd534ff85b	2026-03-16	Warnings	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTRUIZING	Walgreen Co.	27452cc7-1ec6-4571-bcd0-0a7103735ee5	2026-03-13	Warnings, Adverse reactions	Exact identifier application number: M016
Tender Moments Delicate Baby Diaper Rash Balm	DIMETHICONE,ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	f09ba452-e1a6-4f45-901f-bb63d4f8e884	2026-03-13	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259090	dimethicone 5 % Topical Cream	PSN	83f92ac9-4114-4192-926d-be2854a84106	10
259090	dimethicone 50 MG/ML Topical Cream	SCD	83f92ac9-4114-4192-926d-be2854a84106	10
259090	dimethicone 5 % Topical Cream	SY	83f92ac9-4114-4192-926d-be2854a84106	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69740-322-00	69740032200	114 g in 1 TUBE (69740-322-00)	114 g	2005-08-01	0000-00-00	No	No	Current
69740-322-01	69740032201	3.5 g in 1 PACKET (69740-322-01)	3.5 g	2005-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Secura Dimethicone Protectant	Smith & Nephew Medical Ltd \| Swiss-American CDMO, LLC	2024-12-16	HUMAN OTC DRUG LABEL	10
Quinixil	V2 Pharma, LLC \| Swiss-American CDMO, LLC \| Smith & Nephew Medical Ltd \| G&W Laboratories, Inc.	2022-12-14	HUMAN PRESCRIPTION DRUG LABEL	4