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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact 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