FDA.reportPublic FDA data

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
IngredientStrength
PECTIN11.5 mg/3.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2204565Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e5d8234-0521-0c8a-e063-6294a90ae62dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61584-019-01Sootheez Birthday Cake49 g in 1 CANISTERLOZENGE491

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 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsExact identifier
application number: M022
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
application number: M022
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
application number: M022
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
application number: M022
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
application number: M022
Anticavity FluorideSODIUM FLUORIDE AND ACIDULATED PHOSPHATEFamily Dollar (FAMILY WELLNESS)1666fff6-9a8b-40f9-ae53-914152db386b2026-04-01WarningsExact identifier
application number: M022
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
application number: M022
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
application number: M022
ndc (product): 61584-019
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC4e5a67a0-f989-50df-e063-6394a90aae732026-03-31WarningsExact identifier
application number: M022
PeriogelHYDROGEN PEROXIDEPERIO PROTECT, LLC1f9686b1-eac2-65b7-e063-6394a90a74fb2026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
application number: M022
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
application number: M022
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
application number: M022
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2204565pectin 11.5 MG Throat PopPSN4e5d8234-0521-0c8a-e063-6294a90ae62d1
2204565pectin 11.5 MG Oral LozengeSCD4e5d8234-0521-0c8a-e063-6294a90ae62d1
2204565pectin 11.5 MG Throat PopSY4e5d8234-0521-0c8a-e063-6294a90ae62d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61584-019-016158400190149 g in 1 CANISTER (61584-019-01) 49 g2026-02-02NoNoCurrent