FDA.reportPublic FDA data

Flanders Buttocks

Product NDC
54323-215
Requested package NDC
54323-215-02
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-07-28WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016

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

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