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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact 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