FDA.reportPublic FDA data

Flanders Buttocks

Product NDC
54323-215
11-digit product format
543230215
Labeler code
54323
Product ID
54323-215_47fab0f7-e37e-74d5-e063-6294a90a927f
Type
HUMAN OTC DRUG
Nonproprietary name
White petrolatum, zinc oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Flanders Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1986-10-16
Substance
PETROLATUM; ZINC OXIDE
Active strength
66.2; 13.4 g/100g; g/100g
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
Flanders Buttocks
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM66.2 g/100g
ZINC OXIDE13.4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702006Internal RxNorm lookup
1086022Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32371159-c76d-41b0-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54323-215-02Flanders Buttocks113 g in 1 TUBEOINTMENT11311
54323-215-03Flanders Buttocks5 g in 1 PACKETOINTMENT511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54323-215-02GM - Gram54323-2151bfac02f-2726-484e-950c-e67d3b6d31ef12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54323-215FLANDERS BUTTOCKS (WHITE PETROLATUM, ZINC OXIDE) OINTMENT [FLANDERS INC]10Current NDC, Legacy NDC, 2 package rows20241016_32371159-c76d-41b0-e054-00144ff88e88.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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086022Flanders Buttocks Ointment 13.4 % Topical OintmentPSN32371159-c76d-41b0-e054-00144ff88e8811
702006zinc oxide 13.4 % Topical OintmentPSN32371159-c76d-41b0-e054-00144ff88e8811
1086022zinc oxide 0.134 MG/MG Topical Ointment [Flanders]SBD32371159-c76d-41b0-e054-00144ff88e8811
702006zinc oxide 0.134 MG/MG Topical OintmentSCD32371159-c76d-41b0-e054-00144ff88e8811
1086022Flanders 0.134 MG/MG Topical OintmentSY32371159-c76d-41b0-e054-00144ff88e8811
1086022Flanders Buttocks Ointment 13.4 % Topical OintmentSY32371159-c76d-41b0-e054-00144ff88e8811
702006zinc oxide 13.4 % Topical OintmentSY32371159-c76d-41b0-e054-00144ff88e8811
702006ZNO 0.134 MG/MG Topical OintmentSY32371159-c76d-41b0-e054-00144ff88e8811
1086022ZNO 0.134 MG/MG Topical Ointment [Flanders]SY32371159-c76d-41b0-e054-00144ff88e8811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54323-215-0254323021502113 g in 1 TUBE (54323-215-02) 113 g1993-01-010000-00-00NoNoCurrent
54323-215-03543230215035 g in 1 PACKET (54323-215-03) 5 g1986-10-160000-00-00YesNoCurrent