FDA.reportPublic FDA data

Earthmed Soothe Chewable Cherry

Product NDC
82876-984
11-digit product format
828760984
Labeler code
82876
Product ID
82876-984_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 Cherry
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
82876-984-20Earthmed Soothe Chewable Cherry108.27 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 24 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEHarris Teeter, LLC2c65f7f5-195c-ed33-e063-6294a90a30702025-02-11WarningsExact identifier
application number: M001
Regular Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2cb50083-b05f-8aca-e063-6394a90a6d6f2025-02-11WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEHarris Teeter, LLC2c544c08-8cdb-edf2-e063-6394a90a024c2025-02-11WarningsExact identifier
application number: M001
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a28a2-f848-d185-e063-6294a90ab3382025-02-07WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.e4b8f068-ad52-10c8-e053-2a95a90a871f2025-02-07WarningsExact identifier
application number: M001
Regular Strength Peppermint AntacidCALCIUM CARBONATEDeMoulas Market Basket89bdb1c0-df39-4c37-bb0d-0bfd0bff85fb2025-02-07WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1cbea7c2-fdc0-5a6b-e063-6294a90a9cfa2025-02-07WarningsExact identifier
application number: M001
Regular Strength AntacidCALCIUM CARBONATEDeMoulas Market Basketbe167e45-3db8-4739-91ac-e83d552236172025-02-07WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI1b6a4808-4d0b-783c-e063-6394a90af0c32025-02-07WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATEGuardian Drug Company7f0ca229-7452-4f18-bd2f-bf2dfc3482f82025-02-06WarningsExact identifier
application number: M001
Alkums antacidCALCIUM CARBONATEGuardian Drug Company7451cd9f-1723-46d0-837e-8dc48bfb6bba2025-02-06WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATERetail Business Services, LLC.1e97c054-d6b3-425a-e063-6394a90af8362025-02-04WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.214eed56-2d35-8a69-e063-6394a90a15432025-02-04WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHarris Teeter, LLC2bda25ff-9e56-8f8d-e063-6294a90a6a0f2025-02-04WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted FruitCALCIUM CARBONATERetail Business Services, LLC.1ea045ae-0b6a-47ae-e063-6394a90a35be2025-02-04WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATERetail Business Services, LLC.214eb054-b7d0-d19f-e063-6394a90a05ba2025-02-04WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERetail Business Services, LLC.1e987226-02fa-9c10-e063-6294a90a83bf2025-02-04WarningsExact identifier
application number: M001
WONDERBELLY MAXIMUM STRENGTH ANTACIDCALCIUM CARBONATEGinger Health Company2969ce5b-39ae-47b7-e063-6394a90a19092025-02-01WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr (650 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.650fa284-5829-588f-e053-2991aa0a9a0e2025-01-30WarningsExact identifier
application number: M001
Sodium Bicarbonate 5 gr (325 mg)SODIUM BICARBONATECitraGen Pharmaceuticals Inc.68aadbd9-f1c6-8a23-e053-2991aa0afd962025-01-30WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-984-2082876098420108.27 g in 1 BAG (82876-984-20) 108.27 g2025-11-14NoNoCurrent