Oatmeal Skin Relief Calming . 8oz

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Oatmeal Skin Relief Calming . 8oz
Generic name: DIMETHICONE
Manufacturer: Rejoice International Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8384dc52-ba36-da3d-e053-2a91aa0a4f40
SPL ID: 8384b028-7b9c-2a7b-e053-2a91aa0a342c
Version: 1
Effective date: 2019-03-07
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:23:45

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		part347	openfda.application_number
brand name		Oatmeal Skin Relief Calming . 8oz	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Rejoice International Inc.	openfda.manufacturer_name
ndc	package	57337-100-01	openfda.package_ndc
ndc	product	57337-100	openfda.product_ndc
ndc11	package	57337010001	derived:openfda.package_ndc
rxcui		891710	openfda.rxcui
spl id		8384b028-7b9c-2a7b-e053-2a91aa0a342c	id
spl set id		8384dc52-ba36-da3d-e053-2a91aa0a4f40	set_id
unii		92RU3N3Y1O	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Do not use on Deep or puncture wounds Animal bites Serious burns Stop use and ask a doctor if conditions worsens. Symptoms last more than 7 days or clear up and occur again within a few days.

Reported adverse events (FAERS/openFDA)#

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