FDA.reportPublic FDA data

Boudreauxs

Product NDC
0132-0323
11-digit product format
001320323
Labeler code
0132
Product ID
0132-0323_a378c7d3-f792-4c05-b35b-03c8fbb1a5b4
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
C.B. Fleet Company, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-01
Substance
ZINC OXIDE
Active strength
40 g/113g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE40 g/113g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59d90652-a471-4f77-a3d5-88aad9dc9e13Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0323-14Boudreauxs397 g in 1 JARCREAM39713
0132-0323-22Boudreauxs57 g in 1 TUBECREAM5713
0132-0323-44Boudreauxs113 g in 1 TUBECREAM11313
0132-0323-14Boudreauxs Baby Shower Bundle397 g in 1 JARCREAM397 g40 g in 113g3
0132-0323-22Boudreauxs Baby Shower Bundle57 g in 1 TUBECREAM57 g40 g in 113g3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
BALSAM PERUINACTIVE INGREDIENT8P5F881OCYBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0323BOUDREAUXS (ZINC OXIDE) CREAM [C.B. FLEET COMPANY, INC.]11Current NDC, Legacy NDC, 3 package rows20241215_59d90652-a471-4f77-a3d5-88aad9dc9e13.zip
0132-0323BOUDREAUXS BABY SHOWER BUNDLE (ZINC OXIDE) KIT [C.B. FLEET COMPANY, INC.]2Current NDC, Legacy NDC20240202_a289ed3c-3c7a-4eda-bf5e-139203d2e17e.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 14 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4523af69-1a0d-6d18-e063-6394a90ad9d12026-03-30WarningsExact identifier
application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0132-0323-1400132032314397 g in 1 JAR (0132-0323-14) 397 g2012-02-010000-00-00NoNoCurrent
0132-0323-220013203232257 g in 1 TUBE (0132-0323-22) 57 g2012-02-010000-00-00NoNoCurrent
0132-0323-4400132032344113 g in 1 TUBE (0132-0323-44) 113 g2012-02-010000-00-00NoNoCurrent