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FDA Approval

ThroatSpray

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

FDA Approval Summary

Company
Energique, Inc.
DUNS: 789886132
Effective Date
April 29, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Clove(1 [hp_X] in 1 mL)
Glycerin(1 [hp_X] in 1 mL)
Myrrh(2 [hp_X] in 1 mL)
Sage(2 [hp_X] in 1 mL)
thymus serpyllum whole(6 [hp_X] in 1 mL)
baptisia tinctoria root(3 [hp_X] in 1 mL)
Acmella Oleracea Extract(2 [hp_X] in 1 mL)
Goldenseal(6 [hp_X] in 1 mL)
Belladonna(12 [hp_X] in 1 mL)
mercurius solubilis(12 [hp_X] in 1 mL)
Calcium sulfide(15 [hp_X] in 1 mL)
Apis mellifera venom(12 [hp_X] in 1 mL)
Lachesis Extract(12 [hp_X] in 1 mL)
Echinacea angustifolia root(1 [hp_X] in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Apotheca Company

844330915

Manufacturing Establishments1

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

Apotheca Company

Energique, Inc.

Apotheca Company

844330915

Products1

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

ThroatSpray

Product Details

NDC Product Code
44911-0737
Route of Administration
ORAL
Effective Date
April 29, 2025
CloveActive
Code: K48IKT5321Class: ACTIBQuantity: 1 [hp_X] in 1 mL
GlycerinActive
Code: PDC6A3C0OXClass: ACTIBQuantity: 1 [hp_X] in 1 mL
MyrrhActive
Code: JC71GJ1F3LClass: ACTIBQuantity: 2 [hp_X] in 1 mL
SageActive
Code: 065C5D077JClass: ACTIBQuantity: 2 [hp_X] in 1 mL
thymus serpyllum wholeActive
Code: 86H4S6K51NClass: ACTIBQuantity: 6 [hp_X] in 1 mL
baptisia tinctoria rootActive
Code: 5EF0HWI5WUClass: ACTIBQuantity: 3 [hp_X] in 1 mL
Code: 1O11RD9U53Class: ACTIBQuantity: 2 [hp_X] in 1 mL
Code: ZW3Z11D0JVClass: ACTIBQuantity: 6 [hp_X] in 1 mL
Code: WQZ3G9PF0HClass: ACTIBQuantity: 12 [hp_X] in 1 mL
mercurius solubilisActive
Code: 324Y4038G2Class: ACTIBQuantity: 12 [hp_X] in 1 mL
Code: 1MBW07J51QClass: ACTIBQuantity: 15 [hp_X] in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Code: 7S82P3R43ZClass: ACTIBQuantity: 12 [hp_X] in 1 mL
Code: VSW71SS07IClass: ACTIBQuantity: 12 [hp_X] in 1 mL
Code: VB06AV5US8Class: ACTIBQuantity: 1 [hp_X] in 1 mL
Code: 11E6VI8VEGClass: ACTIBQuantity: 4 [hp_X] in 1 mL
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