FDA.reportPublic FDA data

Curology Barrier Balm

Product NDC
82575-302
11-digit product format
825750302
Labeler code
82575
Product ID
82575-302_41386730-2180-aa7e-e063-6394a90ab0d1
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Barrier Balm
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Curology
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-02
Substance
DIMETHICONE 20; PETROLATUM
Active strength
13; 41.9 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Curology Barrier Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE 2013 g/100g
PETROLATUM41.9 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH8YMB5QY0D, 4T6H12BN9U
Rxcui2665902

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82575-302-01Curology Barrier Balm15 g in 1 TUBEOINTMENT156
82575-302-02Curology Barrier Balm1 in 1 CARTONOINTMENT16
82575-302-03Curology Barrier Balm28 g in 1 TUBEOINTMENT286
82575-302-04Curology Barrier Balm1 in 1 CARTONOINTMENT16
82575-302-05Curology Barrier Balm48 g in 1 TUBEOINTMENT486
82575-302-06Curology Barrier Balm1 in 1 CARTONOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82575-302CUROLOGY BARRIER BALM (SKIN BARRIER BALM) OINTMENT [CUROLOGY]4Current NDC, 6 package rows20241228_04b2ba38-0f81-be51-e063-6294a90af821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentPSN04b2ba38-0f81-be51-e063-6294a90af8216
2665902dimethicone 0.13 MG/MG / petrolatum 0.419 MG/MG Topical OintmentSCD04b2ba38-0f81-be51-e063-6294a90af8216
2665902dimethicone 13 % / petrolatum 41.9 % Topical OintmentSY04b2ba38-0f81-be51-e063-6294a90af8216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82575-302-018257503020115 g in 1 TUBE15 gHistorical
82575-302-02825750302021 TUBE in 1 CARTON (82575-302-02) / 15 g in 1 TUBE (82575-302-01) 1 tube2023-10-02NoNoCurrent
82575-302-038257503020328 g in 1 TUBE28 gHistorical
82575-302-04825750302041 TUBE in 1 CARTON (82575-302-04) / 28 g in 1 TUBE (82575-302-03) 1 tube2023-10-02NoNoCurrent
82575-302-058257503020548 g in 1 TUBE48 gHistorical
82575-302-06825750302061 TUBE in 1 CARTON (82575-302-06) / 48 g in 1 TUBE (82575-302-05) 1 tube2023-10-02NoNoCurrent