FDA.reportPublic FDA data

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 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
82876-983-20Earthmed Soothe Chewable Watermelon108.27 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 29 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATION9889cf9e-3f6a-4abc-b723-0b295c7c8f932024-10-30WarningsExact identifier
application number: M001
Rite Aid Pharmacy Extra Strength Assorted BerriesCALCIUM CARBONATERITE AID CORPORATIONf697de02-7df9-4419-9835-8b65bbaf42152024-10-29WarningsExact identifier
application number: M001
Premier Value Smooth Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortium0de2c4c5-46fb-4081-aa96-b36794e3983f2024-10-28WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Extra Strength Tropical FruitANTACID TABLETSChain Drug Consortium8999b9c1-05d0-496b-88f2-062908a4fadc2024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortiumef8ab31b-d050-446a-bca9-4a94d4ba17522024-10-25WarningsExact identifier
application number: M001
Premier Value Extra Strength Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEPHARMACY VALUE ALLIANCE, LLCe33db45a-594e-4af8-ab16-10010fc8a3882024-10-25WarningsExact identifier
application number: M001
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
application number: M001
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
application number: M001
PV Extra Strength AntacidCALCIUM CARBONATEPHARMACY VALUE ALLIANCE, LLC8c92de83-ed60-46c3-b289-4b45a1915e242024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Ultra Strength Assorted FruitANTACID TABLETSChain Drug Consortium26c742a7-5806-44e0-bef0-c70a9d77dd232024-10-25WarningsExact identifier
application number: M001
Premier Value Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Consortium, LLC00a58373-77ab-4a46-9862-d179e17c731a2024-10-25WarningsExact identifier
application number: M001
Premier Value Multi Symptom Antacid Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEPharmacy Value Alliance LLC69e0c4a8-04ae-461b-bf47-4180bccd91d62024-10-25WarningsExact identifier
application number: M001
Premier Value Regular Strength Chewable Antacid Peppermint Assorted FruitANTACID TABLETSChain Drug Consortium, LLC245e195f-fd67-497b-83d4-fef75cea8b5b2024-10-25WarningsExact identifier
application number: M001
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.53380470-5748-6fa7-548e-7484ef204c0f2024-10-21WarningsExact identifier
application number: M001
OHTAS ISAN ANTACIDCALCIUM CARBONATE, SODIUM BICARBONATEOHTA'S ISAN CO.,LTD.8723fe90-8402-4511-b6c6-b71cf98513e32024-10-21WarningsExact identifier
application number: M001
Citrus Flavored AntacidCALCIUM CARBONATEJHK DBA American Safety & First Aid79f2b495-a438-408e-9572-b6c3516db52c2024-10-15WarningsExact identifier
application number: M001
NUTRALOXCALCIUM CARBONATEA-S Medication Solutions524e26a9-c69f-4e25-b83d-f4c65adca83d2024-10-11WarningsExact identifier
application number: M001
Mag-AL LiquidALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDEPAI Holdings, LLCb1f2d137-f5f7-4800-a1df-ef5d25544bc92024-10-08WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCbfc78d44-dc90-4f69-85af-a23dd70c68d22024-10-04WarningsExact identifier
application number: M001
HEB Extra Strength sugar free Antacid 174CALCIUM CARBONATEH E B17cd3717-2fc3-1693-e063-6394a90ae03d2024-09-17WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-983-2082876098320108.27 g in 1 BAG (82876-983-20) 108.27 g2025-11-14NoNoCurrent