Home NDC 61584-019 Sootheez Birthday Cake
Product NDC 61584-019
11-digit product format 615840019
Labeler code 61584
Product ID 61584-019_4e5d8234-0520-0c8a-e063-6294a90ae62d
Type HUMAN OTC DRUG
Nonproprietary name Pectin
Dosage form LOZENGE
Route ORAL
Labeler Primrose Candy Co.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-02
Substance PECTIN
Active strength 11.5 mg/3.5g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sootheez Birthday Cake
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PECTIN 11.5 mg/3.5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89NA02M4RX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2204565 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61584-019-01 Sootheez Birthday Cake 49 g in 1 CANISTER LOZENGE 49 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 28 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61584-019-01 61584001901 49 g in 1 CANISTER (61584-019-01) 49 g 2026-02-02 No No Current