Sootheez Birthday Cake

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: Sootheez Birthday Cake
Generic name: PECTIN
Manufacturer: Primrose Candy Co.
Product type: HUMAN OTC DRUG
SPL set ID: 4e5d8234-0521-0c8a-e063-6294a90ae62d
SPL ID: 4e5d8234-0520-0c8a-e063-6294a90ae62d
Version: 1
Effective date: 2026-03-31
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:26:08

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		M022	openfda.application_number
brand name		Sootheez Birthday Cake	openfda.brand_name
generic name		PECTIN	openfda.generic_name
manufacturer name		Primrose Candy Co.	openfda.manufacturer_name
ndc	package	61584-019-01	openfda.package_ndc
ndc	product	61584-019	openfda.product_ndc
ndc11	package	61584001901	derived:openfda.package_ndc
rxcui		2204565	openfda.rxcui
spl id		4e5d8234-0520-0c8a-e063-6294a90ae62d	id
spl set id		4e5d8234-0521-0c8a-e063-6294a90ae62d	set_id
unii		89NA02M4RX	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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nuasea, or vomiting, consult a doctor promptly. If sore mouth symptoms, do not improve in 7 days, see your denist or doctor promptly. Stop use and ask a doctor if Stop use and ask a doctor if: sore throat does not improve in 7 days irritation, pain, or redness persists or worsens. Keep out of reach of children Keep out of reach of children

Reported adverse events (FAERS/openFDA)#

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