Calming Itch and Irritation

Product NDC
54136-322
Requested package NDC
54136-322-81
11-digit product format
541360322
Labeler code
54136
Product ID
54136-322_eaddaa9e-ae2e-71da-e053-2a95a90a4307
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Better Planet Brands LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-05-11
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
2 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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54136-32254136-322-81DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54136-322CALMING ITCH AND IRRITATION (COLLOIDAL OATMEAL) LOTION [BETTER PLANET BRANDS LLC]5Legacy NDC20240724_a566774a-0ee0-0a7d-e053-2a95a90ac383.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54136-322-8154136032281239 g in 1 TUBE (54136-322-81) 239 g2020-05-110000-00-00NoNoCurrent