FDA.reportPublic FDA data

Lolleez Birthday Cake - Conventional

Product NDC
72427-4615
11-digit product format
724274615
Labeler code
72427
Product ID
72427-4615_59e3f013-4da4-88cc-e063-6294a90ab5cf
Type
HUMAN OTC DRUG
Nonproprietary name
Pectin
Dosage form
LOZENGE
Route
ORAL
Labeler
BFY LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-26
Substance
PECTIN
Active strength
11.5 mg/7g
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
Lolleez Birthday Cake - Conventional
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PECTIN11.5 mg/7g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89NA02M4RXInternal UNII lookup
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2204565Internal RxNorm lookup
2667489Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f561685a-5260-59c6-e053-2a95a90ae206Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72427-4615-0Lolleez Birthday Cake - Conventional7140 g in 1 BOXLOZENGE714011
72427-4615-1Lolleez Birthday Cake - Conventional105 g in 1 POUCHLOZENGE10511
72427-4615-2Lolleez Birthday Cake - Conventional56 g in 1 POUCHLOZENGE5611
72427-4615-3Lolleez Birthday Cake - Conventional196 g in 1 POUCHLOZENGE19611
72427-4615-4Lolleez Birthday Cake - Conventional70 g in 1 CARTONLOZENGE7011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72427-4615LOLLEEZ VARIETY PACK (PECTIN) LOZENGE LOLLEEZ BIRTHDAY CAKE - CONVENTIONAL (PECTIN) LOZENGE LOLLEEZ BIRTHDAY CAKE (PECTIN) LOZENGE LOLLEEZ ORANGE MANGO (PECTIN) LOZENGE LOLLEEZ MIXED BERRY (PECTIN) LOZENGE TUMEEZ VARIETY PACK (CALCIUM CARBONATE) LOZENGE LOLLEEZ STRAWBERRY (PECTIN) LOZENGE LOLLEEZ WATERMELON (PECTIN) LOZENGE SOOTHEEZ STRAWBERRY LEMONADE (PECTIN) LOZENGE TUMEEZ ORGANIC GRAPE (CALCIUM CARBONATE) LOZENGE SOOTHEEZ BERRY LEMONADE (PECTIN) LOZENGE SOOTHEEZ BIRTHDAY CAKE (PECTIN) LOZENGE SOOTHEEZ WATERMELON MINT (PECTIN) LOZENGE TUMEEZ ORGANIC APPLE (CALCIUM CARBONATE) LOZENGE [BFY LLC]10Current NDC, 5 package rows20250509_f561685a-5260-59c6-e053-2a95a90ae206.zip

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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667489calcium carbonate 200 MG Oral LozengePSNf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Throat PopPSNf561685a-5260-59c6-e053-2a95a90ae20611
2667489calcium carbonate 200 MG Oral LozengeSCDf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Oral LozengeSCDf561685a-5260-59c6-e053-2a95a90ae20611
2204565pectin 11.5 MG Throat PopSYf561685a-5260-59c6-e053-2a95a90ae20611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72427-4615-0724274615007140 g in 1 BOX (72427-4615-0) 7140 g2024-09-26NoNoCurrent
72427-4615-172427461501105 g in 1 POUCH (72427-4615-1) 105 g2024-09-26NoNoCurrent
72427-4615-27242746150256 g in 1 POUCH (72427-4615-2) 56 g2025-01-29NoNoCurrent
72427-4615-372427461503196 g in 1 POUCH (72427-4615-3) 196 g2025-01-29NoNoCurrent
72427-4615-47242746150470 g in 1 CARTON (72427-4615-4) 70 g2025-01-29NoNoCurrent