Glad Skin

Product NDC
58443-0548
11-digit product format
584430548
Labeler code
58443
Product ID
58443-0548_dd2c44c3-9355-2d00-e053-2a95a90ad08d
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-12-06
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
0 mg/mL
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

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0548-35844305480350 mL in 1 BOTTLE, PUMP (58443-0548-3) 50 ml2019-12-060000-00-00NoNoCurrent