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 26 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.9119b7f0-3e8a-7be7-e053-2995a90a46342024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.db5941b2-0a04-452a-8fbc-bd5e40fadfb12024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
application number: M001
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid PeppermintCALCIUM CARBONATEGoodSense04950b56-7760-4b6c-8110-86b6a3f795b42024-12-19WarningsExact identifier
application number: M001
Goodsense Regular Strength Antacid PeppermintCALCIUM CARBONATEGoodSense32c04f3e-59f3-44aa-ad92-6724449827102024-12-19WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSensead4d51f6-b55b-45db-b034-fb3da54fbe992024-12-19WarningsExact identifier
application number: M001
TUMS Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
application number: M001
Goodsense Extra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSenseae6270fc-0f8d-4bba-8f12-adba3f07f7c52024-12-19WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEChain Drug Marketing Association Inc.ec729051-72d3-4d1a-8e39-d4495d5c1cf32024-12-18WarningsExact identifier
application number: M001
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact 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