Soothe Chewable

Product NDC
82876-843
11-digit product format
828760843
Labeler code
82876
Product ID
82876-843_2bcab022-6b19-2e20-e063-6294a90ad527
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

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 Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP

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
82876-843-20Soothe Chewable108.27 g in 1 BAGCHEWABLE GEL108.272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82876-843SOOTHE CHEWABLE (CITRIC ACID) CHEWABLE GEL [CAROLINA CANNABIS CREATIONS LLC]2Current NDC, 1 package rows20250117_04a7720f-1e74-7578-e063-6394a90a5eae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-843-2082876084320108.27 g in 1 BAG (82876-843-20) 108.27 g2023-08-01NoNoHistorical