FDA.reportPublic FDA data

Earthmed Soothe Chewable Strawberry

Product NDC
82876-982
11-digit product format
828760982
Labeler code
82876
Product ID
82876-982_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 Strawberry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE1.5 g/108.27g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2968PHW8QPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
439543fe-ceb9-4c5c-e063-6294a90a9b70Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-982-20Earthmed Soothe Chewable Strawberry108.27 g in 1 BAGCHEWABLE GEL108.271

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 17 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC3ff92c9a-987f-468e-9e18-1e3e171ede142025-10-29WarningsExact identifier
application number: M001
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC35b3d9d0-b04d-4f6d-b99d-435233803d4b2025-10-29WarningsExact identifier
application number: M001
Ultra StrengthANTACID TABLETSSAFEWAY4c6cdd81-5145-4a1f-888f-85cf5d856c392025-10-29WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSSAFEWAY8ed35c3b-9878-4889-90f7-a3973cf806e02025-10-29WarningsExact identifier
application number: M001
Publix Regular Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCfd637431-7a08-4454-9cae-a68716d2d0fa2025-10-28WarningsExact identifier
application number: M001
Publix Regular Strength Peppermint FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCc41b6cc2-c852-45fd-858c-c7bedc5dc8822025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Assorted BerryCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCa270fc36-f2b2-4f56-81d4-cf165f6b5abe2025-10-28WarningsExact identifier
application number: M001
Extra Strength Sugar Free Orange Cream FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC4dbdabc4-280d-4c9a-8c54-84afc615c8c72025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Tropical FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC28e8dd03-25cf-43db-8c4d-3aae99be9d532025-10-28WarningsExact identifier
application number: M001
Publix Ultra Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC9e1c883f-016e-4c05-b27a-750d14c0f3e52025-10-28WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,48827658-02f7-4599-a90a-1543b30b9de12025-10-27WarningsExact identifier
application number: M001
Regular Strength AntacidANTACIDWal-Mart Stores,Inc.,6e7cd170-b169-4fc0-bc90-f4421bbd9fcd2025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,febe9d70-9a1f-43a9-8ad0-3134eefc69672025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,d399f927-e80b-4162-a1f1-ef6159d6f7b12025-10-27WarningsExact identifier
application number: M001
equate Sugar Free Extra Strength Antacid Orange Cream FlavorANTACIDWal-Mart Stores,Inc.,53a22b37-66af-4735-b262-15e06ad7bf762025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.841ddf88-a016-4a3c-9508-5d5702883d8f2025-10-27WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEWal-Mart Stores,Inc.,6900fabc-2299-48cf-bbda-c92649cfd0e12025-10-27WarningsExact identifier
application number: M001
equate Ultra Strength Antacid Peppermint FlavorANTACID TABLETSWal-Mart Stores,Inc.,6a18cd92-cc51-401b-9074-fbaa1afb42ac2025-10-27WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidANTACID TABLETSWal-Mart Stores,Inc.,9acdfb08-043d-48a5-95f9-54bcba733c6e2025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWal-Mart Stores,Inc448d1c72-2308-4041-8ba6-dd1e0802cc472025-10-27WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-982-2082876098220108.27 g in 1 BAG (82876-982-20) 108.27 g2025-11-14NoNoCurrent