FDA.reportPublic FDA data

BALMEX MULTI-PURPOSE

Product NDC
52412-450
11-digit product format
524120450
Labeler code
52412
Product ID
52412-450_8460153a-29a3-4b1e-8e15-c1be1176e97c
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Randob Labs,Ltd.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-27
Substance
PETROLATUM
Active strength
511 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BALMEX MULTI-PURPOSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM511 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1492066Internal RxNorm lookup
1492071Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83a9ba1a-b708-47e2-a4a3-ef847e1bb792Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-450-35BALMEX MULTI-PURPOSE99 g in 1 TUBEOINTMENT991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52412-450-35GM - Gram52412-4507c9078ba-8add-423c-89fe-8c45e628d4b212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-450BALMEX MULTI-PURPOSE (PETROLATUM) OINTMENT [RANDOB LABS,LTD.]1Current NDC, Legacy NDC, 1 package rows20181114_83a9ba1a-b708-47e2-a4a3-ef847e1bb792.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
ndc (product): 52412-450

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1492071Balmex Healing 51.1 % Topical OintmentPSN83a9ba1a-b708-47e2-a4a3-ef847e1bb7921
1492066petrolatum 51.1 % Topical OintmentPSN83a9ba1a-b708-47e2-a4a3-ef847e1bb7921
1492071petrolatum 0.511 MG/MG Topical Ointment [Balmex Ointment]SBD83a9ba1a-b708-47e2-a4a3-ef847e1bb7921
1492066petrolatum 0.511 MG/MG Topical OintmentSCD83a9ba1a-b708-47e2-a4a3-ef847e1bb7921
1492071Balmex Ointment 0.511 MG/MG Topical OintmentSY83a9ba1a-b708-47e2-a4a3-ef847e1bb7921
1492071Balmex Ointment 51.1 % Topical OintmentSY83a9ba1a-b708-47e2-a4a3-ef847e1bb7921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-450-355241204503599 g in 1 TUBE (52412-450-35) 99 g2018-11-010000-00-00NoNoCurrent