FDA.reportPublic FDA data

Scarzen

Product NDC
71574-500
11-digit product format
715740500
Labeler code
71574
Product ID
71574-500_5672d48b-d218-46bd-8d40-c77bb6abf1ef
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Village Pharma LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
DIMETHICONE, UNSPECIFIED
Active strength
50 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Scarzen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED50 mg/mL

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
1602161Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1550f4e5-22e2-491f-8184-de65da7234e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71574-500-722021-10-22C16284748780-1ba0f9c33-37f8-a910-e053-dadaa90a0b85Scarzen (Dimethicone 5%)
71574-500-722021-01-29C16284748780-1ba0f9c33-37f8-a910-e053-dadaa90a0b85Scarzen (Dimethicone 5%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71574-500-72Scarzen1 in 1 BOXLOTION15
71574-500-72Scarzen120 mL in 1 BOTTLELOTION1205
71574-500-72Scarzen120 mL in 1 BOTTLELOTION120 mL50 mg in 1mL3
71574-500-72Scarzen1 in 1 BOXLOTION50 mg in 1mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-500-72ML - Milliliter71574-500bd03d91c-89a9-4404-8928-668e1cea1ad412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-500SCARZEN (DIMETHICONE) LOTION [VILLAGE PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20231201_1550f4e5-22e2-491f-8184-de65da7234e6.zip
71574-500SCARZEN (TRIAMCINOLONE ACETONIDE, DIMETHICONE) KIT [VILLAGE PHARMA LLC]3Current NDC, Legacy NDC20241205_4777b129-5f7e-49af-9cf7-65158fdf4348.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016
Softlips VanillaDIMETHICONEThe Mentholatum Company56551008-a4e0-406f-8403-980d2e6b75a02026-03-24WarningsExact identifier
application number: M016
Selan Plus Zinc OxideSELAN PLUS ZINC OXIDETrividia Manufacturing Solutions, Inc07396c61-1dfd-4be7-bddf-0eb570a184632026-03-24WarningsExact identifier
application number: M016
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
application number: M016
MG217 Eczema BodyCOLLOIDAL OATMEALWisconsin Pharmacal Company5f0cfd0c-ae87-f411-e053-2a91aa0ac2512026-03-20WarningsExact identifier
application number: M016
Advanced Formula Scar Defense CreamALLANTOINYantai Aien Biotechnology Co., Ltd.4d5c70f9-da41-b535-e063-6294a90a73f22026-03-19WarningsExact identifier
application number: M016
TriplePaste Adult Care Rash TreatmentZINC OXIDEAdvantice Health, LLC2cf0575c-8d3d-1f16-e063-6294a90a629d2026-03-19WarningsExact identifier
application number: M016
multipurposeZINC OXIDE SKIN PROTECTANTAdvantice Health, LLC291563cc-7491-ce41-e063-6394a90ac6c12026-03-19WarningsExact identifier
application number: M016
Triple Diaper RashZINC OXIDEAdvantice Health, LLCd457c58d-8239-41c4-999e-d0ba237e39452026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry PomegranateCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf4464fb2-ba25-16f2-e053-2a95a90a04062026-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyfea4e5c7-780c-c7f4-e053-6294a90abb392026-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
application number: M016
Advanced Bed Sore Wound HealingALLANTOINYantai Aien Biotechnology Co., Ltd.4d589c18-e597-355a-e063-6394a90a42432026-03-18WarningsExact identifier
application number: M016
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d4427b0-25c3-ddf6-e063-6394a90a61532026-03-17WarningsExact identifier
application number: M016
Colloidal OatmealCOLLOIDAL OATMEALWalmart Inc.4a93f77d-41dc-3bab-e063-6394a90a804b2026-03-16Warnings, Adverse reactionsExact identifier
application number: M016
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
application number: M016
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTRUIZINGWalgreen Co.27452cc7-1ec6-4571-bcd0-0a7103735ee52026-03-13Warnings, Adverse reactionsExact identifier
application number: M016
Tender Moments Delicate Baby Diaper Rash BalmDIMETHICONE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.f09ba452-e1a6-4f45-901f-bb63d4f8e8842026-03-13WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1602161dimethicone 5 % Topical LotionPSN1550f4e5-22e2-491f-8184-de65da7234e65
1602161dimethicone 50 MG/ML Topical LotionSCD1550f4e5-22e2-491f-8184-de65da7234e65
1602161dimethicone 5 % Topical LotionSY1550f4e5-22e2-491f-8184-de65da7234e65
1602161dimethicone 5 % Topical LotionPSN4777b129-5f7e-49af-9cf7-65158fdf43483
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4777b129-5f7e-49af-9cf7-65158fdf43483
1602161dimethicone 50 MG/ML Topical LotionSCD4777b129-5f7e-49af-9cf7-65158fdf43483
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4777b129-5f7e-49af-9cf7-65158fdf43483
1602161dimethicone 5 % Topical LotionSY4777b129-5f7e-49af-9cf7-65158fdf43483
1014314triamcinolone acetonide 0.1 % Topical CreamSY4777b129-5f7e-49af-9cf7-65158fdf43483
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4777b129-5f7e-49af-9cf7-65158fdf43483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71574-500-72715740500721 BOTTLE in 1 BOX (71574-500-72) / 120 mL in 1 BOTTLE1 bottle2018-08-010000-00-00NoNoCurrent