Earthmed Soothe Chewable Watermelon
- Product NDC
- 82876-983
- 11-digit product format
- 828760983
- Labeler code
- 82876
- Product ID
- 82876-983_4395440d-5a64-b9c7-e063-6394a90ab4ac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Citric Acid
- Dosage form
- CHEWABLE GEL
- Route
- ORAL
- Labeler
- Earthmed LLC
- Application
- M001
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-14
- Substance
- CITRIC ACID MONOHYDRATE
- Active strength
- 1.5 g/108.27g
- Pharmacologic classes
- Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Earthmed Soothe Chewable Watermelon
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CITRIC ACID MONOHYDRATE | 1.5 g/108.27g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2968PHW8QP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 439543fe-ceb9-4c5c-e063-6294a90a9b70 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82876-983-20 | Earthmed Soothe Chewable Watermelon | 108.27 g in 1 BAG | CHEWABLE GEL | 108.27 | 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 |
|---|---|---|---|---|---|---|
| TUMS CHEWY BITES | CALCIUM CARBONATE TABLET, CHEWABLE | Lil' Drug Store Products, Inc. | f67bd767-e9f1-2377-e053-2a95a90a0a2d | 2024-03-29 | Warnings | M001 |
| Childrens Robitussin Cough and Cold CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | fcd0a8e0-ac2a-039a-be3c-534195d6bcfd | 2024-03-17 | Warnings | M001 |
| TUMS | CALCIUM CARBONATE | Haleon US Holdings LLC | 35f79dcf-1743-4d9f-aba5-5ead6b056309 | 2024-03-15 | Warnings | M001 |
| TUMS extra strength, smoothies | CALCIUM CARBONATE | Haleon US Holdings LLC | 11078d7c-373b-4c7b-b33b-f1deba613fc1 | 2024-03-14 | Warnings | M001 |
| Tums Chewy Bites Tropical Fruit Smoothie | CALCIUM CARBONATE | Haleon US Holdings LLC | 500f821e-dd27-4c7c-b629-a826b2e57c13 | 2024-03-11 | Warnings | M001 |
| TUMS | CALCIUM CARBONATE | Haleon US Holdings LLC | 3988e3f8-b276-43a0-bdd3-01ddd422c986 | 2024-03-03 | Warnings | M001 |
| TUMS Smoothies | CALCIUM CARBONATE | Haleon US Holdings LLC | 9e54f687-4072-42fd-a14b-af67fe8b6cc4 | 2024-03-03 | Warnings | M001 |
| Tums Regular Strength | CALCIUM CARBONATE | Haleon US Holdings LLC | ac80f627-3f51-425b-8c75-e07363048b00 | 2024-03-03 | Warnings | M001 |
| Tums Chewy Bites Mixed Fruit | CALCIUM CARBONATE | Haleon US Holdings LLC | d341b832-edcf-4cb2-96e1-c303b030c59a | 2024-03-02 | Warnings | M001 |
| Tums Chewy Bites | CALCIUM CARBONATE | Haleon US Holdings LLC | 5090f60f-fa98-470b-bafd-bb64e6b28fcc | 2024-03-02 | Warnings | M001 |
| Tums Chewy Bites | CALCIUM CARBONATE | Haleon US Holdings LLC | 453ceee1-414b-4f4c-8408-eb540a79ca05 | 2024-03-02 | Warnings | M001 |
| Tums Chewy Bites Berry Shake | CALCIUM CARBONATE | Haleon US Holdings LLC | 9043983c-7ee4-4971-8885-36f814bb570f | 2024-03-02 | Warnings | M001 |
| Tums Chewy Delights | CALCIUM CARBONATE | Haleon US Holdings LLC | 189850d0-6f06-45bd-bd7e-9063ee580d0b | 2024-03-02 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Bryant Ranch Prepack | 4493d7c5-f2c3-416e-a5c1-35398fc7f61d | 2024-02-29 | Boxed warning, Warnings | M001 |
| REGULAR STRENGTH ANTACID AND ANTIGAS | ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE | STRATEGIC SOURCING SERVICES LLC | fe04c244-d9b8-2800-e053-6294a90aeedc | 2024-02-06 | Warnings | M001 |
| Mylanta Classic | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | Infirst Healthcare Inc. | 10a4cf29-39ed-87c3-e063-6394a90a4973 | 2024-02-05 | Warnings | M001 |
| Mylanta Vanilla Caramel | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | Infirst Healthcare Inc. | 10a66d74-74b4-3f8d-e063-6394a90a7f00 | 2024-02-05 | Warnings | M001 |
| Mylanta Maximum Strength Vanilla Caramel Flavor | ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE | Infirst Healthcare Inc. | ace5cae4-3a78-41c3-987d-59ce22dca2ac | 2024-01-01 | Warnings | M001 |
| Mylanta Coat and Cool | CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE | INFIRST HEALTHCARE INC. | b6571f7f-e1ea-4034-a46c-4de1d01beec3 | 2024-01-01 | Warnings | M001 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Pharma Nobis, LLC | e42f674b-1a70-6a3c-e053-2995a90afa72 | 2023-12-22 | Warnings | M001 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82876-983-20 | 82876098320 | 108.27 g in 1 BAG (82876-983-20) | 108.27 g | 2025-11-14 | No | No | Current |