FDA.reportPublic FDA data

Colloidal oatmeal

Product NDC
69842-276
11-digit product format
698420276
Labeler code
69842
Product ID
69842-276_49ee2b16-aa95-6b0e-e063-6394a90ab290
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-24
Substance
OATMEAL
Active strength
10.4 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
2027-12-31
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
Colloidal oatmeal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a153842c-d9ce-4658-912b-362a6f20b0aaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-276-32Colloidal oatmeal354 g in 1 BOTTLE, PLASTICCREAM35410
69842-276-98Colloidal oatmeal207 g in 1 TUBECREAM20710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-276COLLOIDAL OATMEAL CREAM [CVS PHARMACY]9Current NDC, Legacy NDC, 2 package rows20250523_a153842c-d9ce-4658-912b-362a6f20b0aa.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Mercy Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.4bac19f3-13bb-8d18-e063-6394a90aa3932026-02-25WarningsExact identifier
application number: M016
Skin Mercy Intense Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.468f21c6-2d6f-1654-e063-6394a90ab2f52026-02-25WarningsExact identifier
application number: M016
Magnet Eye Sheet MaskEYE MASKGuangdong Bisutang Biotechnology Co., LTD4a0a84d4-4024-5ea7-e063-6394a90a2b6c2026-02-24WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEH E Bf0b31d52-2903-487a-aa70-0dbdf4c4d7e72026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEH E Ba8ad595a-c811-4534-82e0-9a01085b4b1e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALH E Bce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMeijer, Inc.12867b23-b203-4bd7-af6d-efddeead26be2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.c7a4b7f2-4de9-470c-9f5b-0142bd9351372026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMBetter Living Brands, LLC75cb8f17-6ef2-403e-ab6e-d8e1e8168ec82026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEBetter Living Brands, LLC1d491635-9605-44fa-9860-ea23e4e8b21c2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMBetter Living Brands, LLCba50f2b2-aff8-42cd-8af0-369060a901fb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
OatmealDIMETHICONEBetter Living Brands, LLCd28c5a60-0597-424f-bf7f-08dca39b22f52026-02-23Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-276-3269842027632354 g in 1 BOTTLE, PLASTIC (69842-276-32) 354 g2021-02-02NoNoCurrent
69842-276-9869842027698207 g in 1 TUBE (69842-276-98) 207 g2020-06-240000-00-00NoNoCurrent