EXTRA STRENGTH BODY

Product NDC
61328-119
11-digit product format
613280119
Labeler code
61328
Product ID
61328-119_471aacb1-39a1-1773-e063-6394a90ad389
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-30
Substance
OATMEAL
Active strength
2 g/100mL
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
EXTRA STRENGTH BODY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8PI54V663Y
Rxcui1189915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61328-119-28EXTRA STRENGTH BODY236 mL in 1 TUBECREAM2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61328-119EXTRA STRENGTH BODY (COLLOIDAL OATMEAL) CREAM [SKINFIX, INC.]6Current NDC, Legacy NDC, 1 package rows20241228_32ba5f29-c037-44dd-b5b1-59001ac50753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN32ba5f29-c037-44dd-b5b1-59001ac507537
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD32ba5f29-c037-44dd-b5b1-59001ac507537
1189915colloidal oatmeal 2 % Topical CreamSY32ba5f29-c037-44dd-b5b1-59001ac507537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61328-119-2861328011928236 mL in 1 TUBE (61328-119-28) 236 ml2022-01-300000-00-00NoNoCurrent