Infants

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: Infants
Generic name: SIMETHICONE
Manufacturer: ATLANTIC BIOLOGICALS CORP.
Product type: HUMAN OTC DRUG
SPL set ID: 27fce442-e328-41d2-bab9-87ab21550c04
SPL ID: 3288018d-5d72-4792-e063-6294a90a2c8c
Version: 2
Effective date: 2025-04-11
Source export date: 2026-10-27
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:05:11

Harmonized routes table
Harmonized routes
ORAL

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 · 19 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M002	openfda.application_number
brand name		Infants	openfda.brand_name
generic name		SIMETHICONE	openfda.generic_name
manufacturer name		ATLANTIC BIOLOGICALS CORP.	openfda.manufacturer_name
ndc	package	17856-1303-4	openfda.package_ndc
ndc	package	17856-1303-2	openfda.package_ndc
ndc	package	17856-1303-5	openfda.package_ndc
ndc	package	17856-1303-3	openfda.package_ndc
ndc	package	17856-1303-1	openfda.package_ndc
ndc	product	17856-1303	openfda.product_ndc
ndc11	package	17856130304	derived:openfda.package_ndc
ndc11	package	17856130302	derived:openfda.package_ndc
ndc11	package	17856130303	derived:openfda.package_ndc
ndc11	package	17856130305	derived:openfda.package_ndc
ndc11	package	17856130301	derived:openfda.package_ndc
rxcui		198857	openfda.rxcui
spl id		3288018d-5d72-4792-e063-6294a90a2c8c	id
spl set id		27fce442-e328-41d2-bab9-87ab21550c04	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 Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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