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 |
|---|---|
| PECTIN | 11.5 mg/3.5g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89NA02M4RX | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2204565 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4e5d8234-0521-0c8a-e063-6294a90ae62d | Available on FDA.report |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry | FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 3573f149-2af9-4c86-e063-6294a90a7b3f | 2025-05-18 | Warnings | M022 |
| Bubble Gum Flavor For Kids 25g 50g | BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 354c1eda-ec5b-a8c7-e063-6294a90a871d | 2025-05-16 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Safeway, Inc. | 8fe2f1df-3264-455d-b62c-953dce171c02 | 2025-05-16 | Warnings | M022 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshener | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 32b632bf-058d-447b-a7fb-a9dd05c1e2b8 | 2025-05-08 | Warnings | M022 |
| Parodontax Active Gum Health Clear Mint | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 | 2025-05-08 | Warnings | M022 |
| Listerine Clinical Solutions Gum Health Icy Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 06e1122b-1100-43c0-e063-6394a90a2e78 | 2025-04-22 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Strategic Sourcing Services LLC | 5260258a-bb1e-43d6-bce1-70a38778a64a | 2025-04-14 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | TARGET Corporation | 93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65 | 2025-04-14 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee467ec4-bd5e-644a-e053-2a95a90ac273 | 2025-04-10 | Warnings | M022 |
| Mouthwash | MENTHOL, METHYL SALICYLATE, THYMOL | Orazen Inc | 873c43df-1d46-359b-e053-2a91aa0a4319 | 2025-04-07 | Warnings | M022 |
| Sensodyne Complete Protection Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | e3cc3146-8aed-4f6b-a252-e379418c2b8d | 2025-03-26 | Warnings | M022 |
| Listerine Freshburst Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee1e1df9-74c6-d24b-e053-2a95a90a43d3 | 2025-03-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | edb9e374-4dba-5823-e053-2a95a90a3da5 | 2025-03-03 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Good Sense (Geiss, Destin & Dunn, Inc.) | cfe9be26-e4a4-413c-a602-2f5948e3bb7a | 2025-03-03 | Warnings | M022 |
| LISTERINE Original Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 78e2e172-09a4-4bf1-9871-d099c49087be | 2025-02-28 | Warnings | M022 |
| WHITE GLO CHARCOAL SENSITIVE | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | a5edb7fd-c637-5447-e053-2995a90a5a6f | 2025-02-26 | Warnings | M022 |
| Glorysmile Toothpaste. | GLORYSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 2ef48156-904d-e42a-e063-6394a90a3cd0 | 2025-02-25 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Walgreens | c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa | 2025-02-21 | Warnings | M022 |
| Sheffield Pain Relief | BENZOCAINE | Sheffield Pharmaceuticals LLC | e21abfdd-373d-42af-9535-fe1571382a65 | 2025-02-19 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Whole Foods Market | a2bb142e-8cbe-481e-bf4f-810ca6d14591 | 2025-02-12 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2204565 | pectin 11.5 MG Throat Pop | PSN | 4e5d8234-0521-0c8a-e063-6294a90ae62d | 1 |
| 2204565 | pectin 11.5 MG Oral Lozenge | SCD | 4e5d8234-0521-0c8a-e063-6294a90ae62d | 1 |
| 2204565 | pectin 11.5 MG Throat Pop | SY | 4e5d8234-0521-0c8a-e063-6294a90ae62d | 1 |
Packages#
| 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 |