FDA.reportPublic FDA data

Baza Cleanse and Protect

Product NDC
11701-047
11-digit product format
117010047
Labeler code
11701
Product ID
11701-047_da60cbba-9a51-4f0d-a6b4-f677f10406b4
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
LOTION
Route
TOPICAL
Labeler
Coloplast Corp
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
DIMETHICONE, UNSPECIFIED
Active strength
20 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
Baza Cleanse and Protect
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED20 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198605Internal RxNorm lookup
1053200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82eff041-0c9d-4261-a6b6-5a041a660074Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-047-052023-12-21Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-222023-12-21Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-052023-01-30Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion
11701-047-222023-01-30Baza Cleanse & Protect ® Skin Protectant All-In-One Perineal Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-047-05Baza Cleanse and Protect227 g in 1 BOTTLELOTION2277
11701-047-22Baza Cleanse and Protect4 g in 1 PACKETLOTION47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-047-05ML - Milliliter11701-0479ab1dbf5-8ea4-4b97-96c9-e336d0e5f8e912012-07-24
11701-047-22GM - Gram11701-047a4f0c42d-5a68-45ac-a118-6b8c8a44189b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
DIMETHICONEACTIVE MOIETY92RU3N3Y1OBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
ALLANTOININACTIVE INGREDIENT344S277G0ZBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
SOYBEAN OILINACTIVE INGREDIENT241ATL177ABAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RBAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-047BAZA CLEANSE AND PROTECT (DIMETHICONE) LOTION [COLOPLAST MANUFACTURING US, LLC]6Current NDC, Legacy NDC, 2 package rows20231222_82eff041-0c9d-4261-a6b6-5a041a660074.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 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Savvy Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATESavvy Care and Cosmetics05ee2662-6a51-6e49-e063-6294a90a4ed72024-12-19WarningsExact identifier
application number: M016
Health Smart Lavender Baby PetroleumWHITE PETROLEUMHome Smart Products5828df37-2a42-4129-8e4e-d5ac9c4c96152024-12-19WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMRejoice International Inc.980d030a-feaf-4a81-865e-f85c661513802024-12-19WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUMRejoice International Inc.caf568aa-3889-41ff-835e-875bb6d9ca792024-12-19WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMRejoice International Inc.a45eb8aa-9fc9-4332-a3ef-0e6fd348fb952024-12-19WarningsExact identifier
application number: M016
Cars PetroleumWHITE PETROLATUMUltra Distributors Inc.9905b5a4-382e-4d2a-b971-37998c14c3302024-12-19WarningsExact identifier
application number: M016
Health Smart Aloe Vera PetroleumWHITE PETROLEUMHome Smart Products2671f2ed-af9d-4234-95bf-def368242a782024-12-19WarningsExact identifier
application number: M016
DCH ScarALLANTOIN 0.5%Derma Care Research Labs, LLC00edbc64-9d32-5751-e063-6294a90a400b2024-12-19WarningsExact identifier
application number: M016
Bamboobies Diaper RashZINC OXIDE 15%Derma Care Research Labs, LLC0411f5e3-03d2-c512-e063-6394a90a37d32024-12-19WarningsExact identifier
application number: M016
Maximum Strength Medicated Foot PowderMEDICATED FOOT POWDERJell Pharmaceuticals Pvt. Ltd.cdaae985-5363-e9d2-e053-2995a90a26822024-12-18WarningsExact identifier
application number: M016
BABY FRESH SCENT PETROLEUMWHITE PETROLEUMJell Pharmaceuticals Pvt Ltd.d80d21cf-9463-7184-e053-2995a90a23f32024-12-18WarningsExact identifier
application number: M016
Health Smart Baby PetroleumWHITE PETROLEUMHome Smart Productsedd9d018-c2c9-4a9a-b727-0a92cd463c022024-12-18WarningsExact identifier
application number: M016
Health Smart Cocoa Butter PetroleumWHITE PETROLEUMHome Smart Productsa65c8267-d34f-4542-a7ca-5180e860a03d2024-12-18WarningsExact identifier
application number: M016
Princess PetroleumWHITE PETROLATUMUltra Distributors Inc.6d9c92bf-9263-40a4-acac-5c3f0b08c69d2024-12-18WarningsExact identifier
application number: M016
Meijer Petroleum JellyWHITE PETROLATUMMeijer Distribution, Incb299cf2a-2c6a-68f4-e053-2995a90a5bd72024-12-18WarningsExact identifier
application number: M016
Foster and Thrive CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services, LLC29945734-4ea6-b702-e063-6294a90ae6f22024-12-18WarningsExact identifier
application number: M016
Foster and Thrive Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEStrategic Sourcing Services, LLC29946912-9794-8a8e-e063-6394a90a279e2024-12-18WarningsExact identifier
application number: M016
Caring Mills Petroleum JellyWHITE PETROLATUMVeridian Healthcarefbbfa780-0e2b-1874-e053-6394a90a5eeb2024-12-18WarningsExact identifier
application number: M016
Serawise Eczema RescueOATMEALDrAnaMaria.com LLCe805866a-2349-4b86-bc83-a7c859cb94032024-12-18WarningsExact identifier
application number: M016
TheraCare Petroleum JellyWHITE PETROLATUMVeridian Healthcared6fad49b-8a49-7f7c-e053-2a95a90ae6382024-12-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053200Baza Cleanse and Protect 2 % Topical LotionPSN82eff041-0c9d-4261-a6b6-5a041a6600747
198605dimethicone 2 % Topical LotionPSN82eff041-0c9d-4261-a6b6-5a041a6600747
1053200dimethicone 20 MG/ML Topical Lotion [Baza Cleanse and Protect]SBD82eff041-0c9d-4261-a6b6-5a041a6600747
198605dimethicone 20 MG/ML Topical LotionSCD82eff041-0c9d-4261-a6b6-5a041a6600747
1053200Baza Cleanse and Protect 2 % Topical LotionSY82eff041-0c9d-4261-a6b6-5a041a6600747
1053200Baza Cleanse and Protect 2 % Topical SpraySY82eff041-0c9d-4261-a6b6-5a041a6600747
1053200Baza Cleanse and Protect 20 MG/ML Topical LotionSY82eff041-0c9d-4261-a6b6-5a041a6600747
198605dimethicone 2 % Topical LotionSY82eff041-0c9d-4261-a6b6-5a041a6600747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-047-0511701004705227 g in 1 BOTTLE (11701-047-05) 227 g2009-06-150000-00-00NoNoCurrent
11701-047-22117010047224 g in 1 PACKET (11701-047-22) 4 g2009-06-150000-00-00NoNoCurrent