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

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 1 of 71 · 1,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact 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