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 Identifiers#

Field, Values table
FieldValues
Unii4T6H12BN9U, SOI2LOH54Z
Rxcui702006, 1086022

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

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