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		2026-10-05

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 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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	8cbe9b1f-fec0-9579-e053-2995a90ac461	2026-06-22	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Walmart Inc.	e294a871-ae73-4a4f-89a3-9ebf0b4fd03a	2026-06-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Foshan Desha Biotechnology Co., Ltd.	5487ad62-3d73-042e-e063-6394a90afe8c	2026-06-18	Warnings	Exact identifier application number: M016
Baby HealingOintment	PETROLATUM	Foshan Desha Biotechnology Co., Ltd.	5488b81a-e5fe-1452-e063-6394a90a2ae4	2026-06-18	Warnings	Exact identifier application number: M016
Baby Eczema Moisturizing Cream	COLLOIDAL OATMEAL	Foshan Desha Biotechnology Co., Ltd.	548a0c34-6aac-14f7-e063-6394a90ae652	2026-06-18	Warnings	Exact identifier application number: M016
Jell with Vitamin A D	LANOLIN, PETROLATUM	Jell Pharmaceuticals Pvt Ltd.	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	2026-06-17	Warnings	Exact identifier application number: M016
Dove	ANTIBACTERIAL CARE BEAUTY BAR	Conopco d/b/a Unilever	547472cf-4902-584e-e063-6294a90a28ac	2026-06-17	Warnings	Exact identifier application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing Balm	LANOLIN	Herstat (USA) Inc.	389041a8-7316-b38e-e063-6294a90a3e8e	2026-06-17	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	546749e3-70c5-10e8-e063-6294a90ad8c4	2026-06-16	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	54698388-f9e8-c470-e063-6394a90a783b	2026-06-16	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE	Medline Industries, LP	3c319953-04fc-87a8-e063-6294a90a5058	2026-06-15	Warnings	Exact identifier application number: M016
Calamine, Pramoxind HCl	CALAMINE, PRAMOXIND HCL	H E B	4a7a0b09-d9bc-e752-e063-6394a90a9f2c	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine, Zinc Oxide	CALAMINE, ZINC OXIDE	H E B	4a79259e-64ac-d187-e063-6294a90a78db	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
HEALMUSZ HEALTHY FEET	UREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEET	Jiangxi Yudexi Pharmaceutical Co., LTD	4a34b6de-03ec-3be4-e063-6294a90afb52	2026-06-14	Warnings	Exact identifier application number: M016
PUVIDA SNOW BLEACH	NIACINAMIDE 15% SNOW BLEACH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a48ebbd-7c80-1bce-e063-6294a90ab4ae	2026-06-14	Warnings	Exact identifier application number: M016
XIMONTH Foot Shoe Deodorizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	541d9ce9-62ad-847e-e063-6394a90a55e0	2026-06-13	Warnings	Exact identifier application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing Cream	PETROLATUM	Aldermed Inc.	87413149-d39f-4f8a-b1c9-6de5eb37ff7e	2026-06-12	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE, WHITE PETROLATUM	Aldermed Inc.	54154a72-27ad-7bfa-e063-6394a90a4eca	2026-06-12	Warnings	Exact identifier application number: M016
Circletong Tag Wart Remover Patches	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	541b0fe9-f900-8191-e063-6394a90af321	2026-06-12	Warnings	Exact identifier application number: M016
Baby Butz	ZINC OXIDE	Olen Skin Care Corporation	e6be6b62-13a4-410d-b8ac-457b58fd23da	2026-06-10	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