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FDA Approval

JBA Collagen-Electrolyte Mocktail

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
March 31, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Thiamine(1.2 mg in 12 g)
Vitamin C(100 mg in 12 g)
Pyridoxine(2.5 mg in 12 g)
Biotin(80 ug in 12 g)
Dexpanthenol(6 mg in 12 g)
Potassium(190 mg in 12 g)
Riboflavin(1.6 mg in 12 g)
Niacin(18 mg in 12 g)
Folic acid(200 ug in 12 g)
Magnesium(50 mg in 12 g)
Zinc(10 mg in 12 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

187498279

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

JBA Collagen-Electrolyte Mocktail

Product Details

NDC Product Code
13411-848
Route of Administration
ORAL
Effective Date
March 31, 2025
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 1.2 mg in 12 g
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 12 g
Code: KV2JZ1BI6ZClass: ACTIBQuantity: 2.5 mg in 12 g
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 80 ug in 12 g
Code: 19F5HK2737Class: ACTIBQuantity: 6 mg in 12 g
PotassiumActive
Code: RWP5GA015DClass: ACTIBQuantity: 190 mg in 12 g
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
Code: TLM2976OFRClass: ACTIBQuantity: 1.6 mg in 12 g
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
STEVIA REBAUDIUNA LEAFInactive
Code: 6TC6NN0876Class: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
NiacinActive
Code: 2679MF687AClass: ACTIBQuantity: 18 mg in 12 g
Code: 935E97BOY8Class: ACTIBQuantity: 200 ug in 12 g
MagnesiumActive
Code: I38ZP9992AClass: ACTIBQuantity: 50 mg in 12 g
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 10 mg in 12 g
Code: 9NEZ333N27Class: ACTIBQuantity: 250 mg in 12 g
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