SanaTos Children Cough and Congestion Cherry

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: SanaTos Children Cough and Congestion Cherry
Generic name: DEXTROMETHORPHAN HBR AND GUAIFENESIN
Manufacturer: Pharmadel LLC
Product type: HUMAN OTC DRUG
SPL set ID: 60437d86-9e13-8d8a-e053-2991aa0a2317
SPL ID: 177ee8db-2b19-2923-e063-6294a90a1c7b
Version: 4
Effective date: 2024-05-02
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:37:04

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		SanaTos Children Cough and Congestion Cherry	openfda.brand_name
generic name		DEXTROMETHORPHAN HBR AND GUAIFENESIN	openfda.generic_name
manufacturer name		Pharmadel LLC	openfda.manufacturer_name
ndc	package	55758-013-04	openfda.package_ndc
ndc	product	55758-013	openfda.product_ndc
ndc11	package	55758001304	derived:openfda.package_ndc
rxcui		1020138	openfda.rxcui
spl id		177ee8db-2b19-2923-e063-6294a90a1c7b	id
spl set id		60437d86-9e13-8d8a-e053-2991aa0a2317	set_id
unii		9D2RTI9KYH	openfda.unii
unii		495W7451VQ	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 Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use, if the child has a cough that is accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor, if the child has a cough that lasts more than 7 days, tends to recur, or is accompanied by fever, rash or a persistent headache. These could be signs of a serious condition. KEEP OUT OF REACH OF CHILDREN. In case of overdose, 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.