FDA.reportPublic FDA data

Sween 24

Product NDC
11701-063
11-digit product format
117010063
Labeler code
11701
Product ID
11701-063_8435a838-1f5b-4d98-95eb-2f1b684a0e74
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Coloplast Corp
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
DIMETHICONE, UNSPECIFIED
Active strength
60 mg/g
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
Sween 24
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED60 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
577215Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a623c8d7-8db0-410a-9980-02ac02f7b6eaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-063-702023-12-21Sween ® 24
11701-063-712023-12-21Sween ® 24
11701-063-722023-12-21Sween ® 24
11701-063-732023-12-21Sween ® 24
11701-063-702023-01-30Sween ® 24
11701-063-712023-01-30Sween ® 24
11701-063-722023-01-30Sween ® 24
11701-063-732023-01-30Sween ® 24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-063-70Sween 24256 g in 1 TUBECREAM2569
11701-063-71Sween 24142 g in 1 TUBECREAM1429
11701-063-72Sween 244 g in 1 PACKETCREAM49
11701-063-73Sween 2457 g in 1 TUBECREAM579

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-063-13GM - Gram11701-0631255ab68-642d-47d0-b37d-faf8a31df53012013-02-11
11701-063-14GM - Gram11701-063d8df7f01-978a-4db5-ad98-e48d3f30cc7912013-02-11
11701-063-22GM - Gram11701-063a6d5fd11-dd85-4d50-83b8-ef79856575ba12015-10-02
11701-063-23GM - Gram11701-063540c564e-0137-42ac-85b8-39f8a505e1b012012-07-24
11701-063-71GM - Gram11701-0632e0846d0-b6f8-4bb2-8c2e-fad7bc527b5012026-04-20
11701-063-73GM - Gram11701-06369e6301a-2f54-4ab7-8134-303ef092a8e712024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61SWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RSWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-063SWEEN 24 (DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]8Current NDC, Legacy NDC, 4 package rows20231222_a623c8d7-8db0-410a-9980-02ac02f7b6ea.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
577215dimethicone 6 % Topical CreamPSNa623c8d7-8db0-410a-9980-02ac02f7b6ea9
577215dimethicone 60 MG/ML Topical CreamSCDa623c8d7-8db0-410a-9980-02ac02f7b6ea9
577215dimethicone 6 % Topical CreamSYa623c8d7-8db0-410a-9980-02ac02f7b6ea9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-063-7011701006370256 g in 1 TUBE (11701-063-70) 256 g2009-06-150000-00-00NoNoCurrent
11701-063-7111701006371142 g in 1 TUBE (11701-063-71) 142 g2009-06-150000-00-00NoNoCurrent
11701-063-72117010063724 g in 1 PACKET (11701-063-72) 4 g2009-06-150000-00-00NoNoCurrent
11701-063-731170100637357 g in 1 TUBE (11701-063-73) 57 g2009-06-150000-00-00NoNoCurrent