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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69740-32269740-322-01DDiscontinued by firm2026-10-15

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69740-322-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69740-322-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69740-322-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69740-322-00IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69740-322-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69740-322-00IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69740-322-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69740-322-00IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69740-322-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69740-322-00IInactivated by FDA1332a3947898…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
IngredientStrength
DIMETHICONE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83f92ac9-4114-4192-926d-be2854a84106Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-322-00Secura Dimethicone Protectant114 g in 1 TUBECREAM11410
69740-322-01Secura Dimethicone Protectant3.5 g in 1 PACKETCREAM3.510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-322-00GM - Gram69740-3220d4d9c45-cef4-4169-9c68-d771aa2facc312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-322SECURA DIMETHICONE PROTECTANT (DIMETHICONE) CREAM [SMITH & NEPHEW MEDICAL LTD]10Current NDC, Legacy NDC, 2 package rows20241218_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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
application number: M016
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
application number: M016
Zinc OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
application number: M016
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCcf888bf3-6950-43aa-b4be-5a32961b4d962023-11-15WarningsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
application number: M016
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
application number: M016
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash Max StrengthZINC OXIDEGeodis Logistics LLC1b4fd6cb-f2dc-40a2-b958-e99caec917932023-11-10WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash OriginalZINC OXIDEGeodis Logistics LLC97587458-4ca0-4de3-9bb9-148346d859c02023-11-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259090dimethicone 5 % Topical CreamPSN83f92ac9-4114-4192-926d-be2854a8410610
259090dimethicone 50 MG/ML Topical CreamSCD83f92ac9-4114-4192-926d-be2854a8410610
259090dimethicone 5 % Topical CreamSY83f92ac9-4114-4192-926d-be2854a8410610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69740-322-0069740032200114 g in 1 TUBE (69740-322-00) 114 g2005-08-010000-00-00NoNoCurrent
69740-322-01697400322013.5 g in 1 PACKET (69740-322-01) 3.5 g2005-08-010000-00-00NoNoCurrent