Aveeno Baby Calming Comfort

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: Aveeno Baby Calming Comfort
Generic name: DIMETHICONE
Manufacturer: Kenvue Brands LLC
Product type: HUMAN OTC DRUG
SPL set ID: 567b1481-b783-45f9-af38-5630c9edf044
SPL ID: 21eb4c57-d7ff-d06c-e063-6394a90ae472
Version: 5
Effective date: 2024-11-01
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:04:08

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M016	openfda.application_number
brand name		Aveeno Baby Calming Comfort	openfda.brand_name
generic name		DIMETHICONE	openfda.generic_name
manufacturer name		Kenvue Brands LLC	openfda.manufacturer_name
ndc	package	69968-0629-8	openfda.package_ndc
ndc	package	69968-0629-1	openfda.package_ndc
ndc	product	69968-0629	openfda.product_ndc
ndc11	package	69968062901	derived:openfda.package_ndc
ndc11	package	69968062908	derived:openfda.package_ndc
rxcui		876980	openfda.rxcui
spl id		21eb4c57-d7ff-d06c-e063-6394a90ae472	id
spl set id		567b1481-b783-45f9-af38-5630c9edf044	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 Do not get into eyes. Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days. Do not use on Deep or puncture wounds Animal bites Serious burns . Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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