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: RUGBY LABORATORIES
Product type: HUMAN OTC DRUG
SPL set ID: c6fa71bc-de48-47f4-80c4-7d92643d2664
SPL ID: 41f5317f-a058-f03c-e063-6394a90a321a
Version: 6
Effective date: 2025-10-25
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:42:33

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 · 11 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		RUGBY LABORATORIES	openfda.manufacturer_name
ndc	package	0536-1303-75	openfda.package_ndc
ndc	product	0536-1303	openfda.product_ndc
ndc11	package	00536130375	derived:openfda.package_ndc
rxcui		198857	openfda.rxcui
spl id		41f5317f-a058-f03c-e063-6394a90a321a	id
spl set id		c6fa71bc-de48-47f4-80c4-7d92643d2664	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.