Home NDC 69968-0755 Aveeno Calm Plus Restore Skin Therapy Balm
Product NDC 69968-0755
11-digit product format 699680755
Labeler code 69968
Product ID 69968-0755_36bdeede-e154-67e7-e063-6294a90ac506
Type HUMAN OTC DRUG
Nonproprietary name Colloidal Oatmeal
Dosage form CREAM
Route TOPICAL
Labeler Kenvue Brands LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-28
Substance OATMEAL
Active strength 10 mg/g
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 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 Aveeno Calm Plus Restore Skin Therapy Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OATMEAL 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8PI54V663Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0755-2 Aveeno Calm Plus Restore Skin Therapy Balm 1 in 1 CARTON CREAM 1 5 69968-0755-2 Aveeno Calm Plus Restore Skin Therapy Balm 48 g in 1 TUBE CREAM 48 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0755 AVEENO CALM PLUS RESTORE SKIN THERAPY BALM (COLLOIDAL OATMEAL) CREAM [KENVUE BRANDS LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241107_dbe7a2cc-9c21-2a48-e053-2a95a90a54e2.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 28 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69968-0755-2 69968075502 1 TUBE in 1 CARTON (69968-0755-2) / 48 g in 1 TUBE 1 tube 2022-07-28 0000-00-00 No No Current