FDA.reportPublic FDA data

Boudreauxs Butt Barrier

Product NDC
0132-0326
11-digit product format
001320326
Labeler code
0132
Product ID
0132-0326_e672338e-7f83-42a4-bd2c-9d39959e235c
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
C.B. Fleet Company, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
DIMETHICONE
Active strength
1 g/113g
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
Boudreauxs Butt Barrier
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1 g/113g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06a5af4d-40dd-42a4-8368-4d6a772d1b3aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0326-04Boudreauxs Butt Barrier113 g in 1 TUBEOINTMENT1133
0132-0326-04Boudreauxs Baby Shower Bundle113 g in 1 TUBEOINTMENT113 g1 g in 113g3
0132-0326-04Boudreauxs Baby Shower Bundle1 in 1 CARTONOINTMENT1 g in 113g3
0132-0326-04Boudreauxs Butt Barrier1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0326BOUDREAUXS BABY SHOWER BUNDLE (ZINC OXIDE) KIT [C.B. FLEET COMPANY, INC.]2Current NDC, Legacy NDC20240202_a289ed3c-3c7a-4eda-bf5e-139203d2e17e.zip
0132-0326BOUDREAUXS BUTT BARRIER (DIMETHICONE) OINTMENT [C.B. FLEET COMPANY, INC.]2Current NDC, Legacy NDC, 2 package rows20241121_06a5af4d-40dd-42a4-8368-4d6a772d1b3a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0326-04001320326041 TUBE in 1 CARTON (0132-0326-04) / 113 g in 1 TUBE1 tube2022-03-010000-00-00NoNoCurrent