Soothe Chewable

Product NDC
82876-841
11-digit product format
828760841
Labeler code
82876
Product ID
82876-841_2bcab1d4-51f6-55ed-e063-6394a90a0229
Type
HUMAN OTC DRUG
Nonproprietary name
Citric Acid
Dosage form
CHEWABLE GEL
Route
ORAL
Labeler
Carolina Cannabis Creations LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct82876-841UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82876-84182876-841-20UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Soothe Chewable
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
04a78060-7f0d-c4bd-e063-6294a90ae152Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-841-20Soothe Chewable108.27 g in 1 BAGCHEWABLE GEL108.272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82876-841SOOTHE CHEWABLE (CITRIC ACID) CHEWABLE GEL [CAROLINA CANNABIS CREATIONS LLC]2Current NDC, 1 package rows20250117_04a78060-7f0d-c4bd-e063-6294a90ae152.zip

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 28 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Extra Strength Antacid Extra Strength Antacid Assorted BerryCALCIUM CARBONATETopco Associates, LLC0aefbd70-4103-410c-83b2-f7baa0b80ddd2024-12-09WarningsExact identifier
application number: M001
Topcare Extra Strength Antacid Assorted Fruit Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates, LLC563a9951-0d40-448b-bf0d-8f6d905087d02024-12-09WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3cdfa932-6a20-2a82-e054-00144ff88e882024-12-05WarningsExact identifier
application number: M001
TUMS EXCALCIUM CARBONATEHaleon US Holdings LLC593a0494-d669-4bcf-8412-b92645b2d76c2024-12-05WarningsExact identifier
application number: M001
First Aid Only AntacidCALCIUM CARBONATEAcme United Corporation68902dda-a13c-ff2e-e053-2991aa0a06b12024-11-26WarningsExact identifier
application number: M001
Antacid Peppermint Flavour Regular StrengthCALCIUM CARBONATEAmerican Health Packaging782398a8-a3d9-4766-a7e1-ceb6d65152b22024-11-21WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGLil' Drug Store products, Inc.0803ad9c-1da8-a556-e063-6294a90add7f2024-11-20WarningsExact identifier
application number: M001
CHOOZCALCIUM CARBONATELeosons Overseas Corp.9faf82d9-ed83-4007-b580-117d7e7fefc72024-11-18WarningsExact identifier
application number: M001
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEPAI Holdings, LLC dba PAI Pharmad89f3184-7081-4e16-a504-9214283891f62024-11-12WarningsExact identifier
application number: M001
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATIONd2f8dcc2-8833-4426-9c12-1a60871451222024-10-30WarningsExact identifier
application number: M001
RITE AID Pharmacy Ultra Strength Assorted FruitsCALCIUM CARBONATERITE AID CORPORATION2989649c-e5ab-4118-a4d4-0f22a7f9f0a02024-10-30WarningsExact identifier
application number: M001
Kids AntacidCALCIUM CARBONATERITE AID CORPORATION9255322d-dd0d-4429-b1ca-805c7348c38d2024-10-30WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATERITE AID CORPORATION23fa3378-d9f9-4671-ba1c-9c9611b1fbef2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Assorted FruitCALCIUM CARBONATERITE AID CORPORATIONd405655a-260d-4a26-bf6f-053c6a6c87af2024-10-30WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATERITE AID CORPORATIONc6bbffbc-2d00-4a5c-80aa-5e59204cca9f2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Assorted FruitsCALCIUM CARBONATERITE AID CORPORATION60d5fa96-528e-486c-ada2-cdfef090b61a2024-10-30WarningsExact identifier
application number: M001
Rite Aid Ultra Strength Peppermint FlavorCALCIUM CARBONATERITE AID CORPORATION4e963099-fd7f-4862-9f9c-9f1fb963779e2024-10-30WarningsExact identifier
application number: M001
Rite Aid Ultra Strength Assorted BerriesCALCIUM CARBONATERITE AID CORPORATIONea918cb1-af3e-4a02-bd34-db4ad1b0e6bd2024-10-30WarningsExact identifier
application number: M001
Rite Aid Extra Strength Tropical FruitCALCIUM CARBONATERite Aid Corporationffb9d2bf-0818-4109-a6f9-2f0ac74b872c2024-10-30WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-841-2082876084120108.27 g in 1 BAG (82876-841-20) 108.27 g2023-08-01NoNoCurrent