Avene XERACALM Eczema Calming Relief Balm

Product NDC
64760-777
11-digit product format
647600777
Labeler code
64760
Product ID
64760-777_26443c1f-2af2-eaf3-e063-6294a90acf57
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Pierre Fabre USA Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
OATMEAL
Active strength
1 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avene XERACALM Eczema Calming Relief Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui240651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64760-777-01Avene XERACALM Eczema Calming Relief Balm100 g in 1 TUBECREAM1003
64760-777-02Avene XERACALM Eczema Calming Relief Balm5 g in 1 TUBECREAM53
64760-777-02Avene XERACALM Eczema Calming Relief Balm1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64760-777AVENE XERACALM ECZEMA CALMING RELIEF BALM (COLLOIDAL OATMEAL) CREAM [PIERRE FABRE USA INC.]3Current NDC, 3 package rows20241108_1315f006-0e96-2074-e063-6394a90a6037.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1315f006-0e96-2074-e063-6394a90a60373
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1315f006-0e96-2074-e063-6394a90a60373
240651Avena sativa 1 % Topical CreamSY1315f006-0e96-2074-e063-6394a90a60373
240651colloidal oatmeal 1 % Topical CreamSY1315f006-0e96-2074-e063-6394a90a60373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64760-777-0164760077701100 g in 1 TUBE (64760-777-01) 100 g2024-05-01NoNoCurrent
64760-777-02647600777021 TUBE in 1 BOX (64760-777-02) / 5 g in 1 TUBE1 tube2024-06-03YesNoCurrent