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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herpecin Pain Relief	ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL	Focus Consumer Healthcare, LLC	beeb6043-6547-4fe9-e053-2995a90a5d74	2026-04-30	Warnings	Exact identifier application number: M016
CVS	PETROLATUM	Apollo Health and Beauty Care	47d2b9be-91ad-e9e2-e063-6294a90ac29f	2026-04-30	Warnings	Exact identifier application number: M016
Dr. Numb	LIDOCAINE	Shinpharma Inc	0578fbcb-875a-4606-acde-dcecb29756e6	2026-04-30	Warnings	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Amazon.com Services LLC	423c821d-92af-47f0-b9ee-8b68ecbcc44e	2026-04-29	Warnings, Adverse reactions	Exact identifier application number: M016
MICRO INFUSIONSYSTEM	SEEK GLO	Ningbo Kenwei International Trade Co., Ltd.	50746cab-bfcc-fe0b-e063-6394a90adc01	2026-04-27	Warnings	Exact identifier application number: M016
Pharmacy Choice	MENTHOL, ZINC OXIDE	PHARMACY CHOICE INC	5031fc05-e1c7-40b1-e063-6394a90aa12c	2026-04-24	Warnings	Exact identifier application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION	SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY	Guangzhou Ariel Biotech Co., Ltd.	5040b707-87af-3859-e063-6294a90afb3d	2026-04-24	Warnings	Exact identifier application number: M016
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier application number: M016
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier application number: M016
Arm and Hammer Baking Soda	SODIUM BICARBONATE	Church & Dwight Co., Inc.	643fe204-4a7b-00e4-e053-2a91aa0aef06	2026-04-21	Warnings	Exact identifier application number: M016
PURE PETROLATUM	PETROLATUM	MY IMPORTS USA LLC	4fba8bc7-590d-f621-e063-6294a90ad8c9	2026-04-18	Warnings	Exact identifier application number: M016
Anti-Itch Regular Strength	HYDROCORTISONE	CVS Pharmacy	9fe7768b-9023-c9ee-e053-2a95a90a55b3	2026-04-17	Warnings	Exact identifier application number: M016
Calamine Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Pharma Nobis, LLC	4f853183-5925-2c73-e063-6394a90adf6c	2026-04-15	Warnings	Exact identifier application number: M016
Freskaro Calamine Plus	ZINC OXIDE LOTION	Pharma Nobis, LLC	4f85bdc7-8fed-f1f5-e063-6394a90a6358	2026-04-15	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE OINTMENT	Dynarex Corporation	11d79dd6-35f7-4399-e063-6294a90ac7dd	2026-04-13	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f261746-37e9-7b30-e063-6294a90a9224	2026-04-10	Warnings	Exact identifier application number: M016
FB HYDRATING HAND SANITIZER	FB HYDRATING HAND SANITIZER	FAMILY DOLLAR SERVICES, LLC	4f268501-6cd7-7edd-e063-6294a90ac649	2026-04-10	Warnings	Exact identifier application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENT	DIMETHICONE	Beverly Hills MD, LLC	4ed33a43-d059-2589-e063-6294a90a30b3	2026-04-09	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	WAL-MART STORES INC	00faa772-53f3-9276-e063-6394a90a2dab	2026-04-07	Warnings	Exact identifier application number: M016
ProCure Zinc Oxide	ZINC OXIDE	Twin Med LLC	37a30ee5-fd33-b410-e063-6294a90aef72	2026-04-07	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