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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H8YMB5QY0DInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2665902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04b2ba38-0f81-be51-e063-6294a90af821Available on FDA.report

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

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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42762471-e5cd-505e-e063-6294a90afb7d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016

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