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FDA Approval

Airway Ease

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

FDA Approval Summary

Company
Effective Date
May 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
bryonia alba root(15 [hp_X] in 1 mL)
arctium lappa root(6 [hp_X] in 1 mL)
spongia officinalis skeleton, roasted(15 [hp_X] in 1 mL)
tussilago farfara(15 [hp_X] in 1 mL)
verbascum thapsus(15 [hp_X] in 1 mL)
Echinacea(6 [hp_X] in 1 mL)
Antimony potassium tartrate(15 [hp_X] in 1 mL)
Arsenic trioxide(15 [hp_X] in 1 mL)
chelidonium majus(15 [hp_X] in 1 mL)
cinchona officinalis bark(15 [hp_X] in 1 mL)
drosera anglica(15 [hp_X] in 1 mL)
Eucalyptus gum(15 [hp_X] in 1 mL)
Histamine(15 [hp_X] in 1 mL)
Goldenseal(15 [hp_X] in 1 mL)
Potassium carbonate(15 [hp_X] in 1 mL)
Potassium Iodide(15 [hp_X] in 1 mL)
Myrrh(15 [hp_X] in 1 mL)
Sodium sulfate(15 [hp_X] in 1 mL)
Phosphorus(15 [hp_X] in 1 mL)
anemone pulsatilla(15 [hp_X] in 1 mL)
Sambucus nigra flowering top(15 [hp_X] in 1 mL)
Nux vomica extract(15 [hp_X] in 1 mL)
Potassium(15 [hp_X] in 1 mL)
Rumex crispus whole(15 [hp_X] in 1 mL)

Registrants1

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

Newton Laboratories, Inc.

788793610

Manufacturing Establishments1

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

Newton Laboratories, Inc.

Newton Laboratories, Inc.

Newton Laboratories, Inc.

788793610

Products1

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

Airway Ease

Product Details

NDC Product Code
55714-1536
Route of Administration
ORAL
Effective Date
May 7, 2025
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 15 [hp_X] in 1 mL
arctium lappa rootActive
Code: 597E9BI3Z3Class: ACTIBQuantity: 6 [hp_X] in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
spongia officinalis skeleton, roastedActive
Code: 1PIP394IIDClass: ACTIBQuantity: 15 [hp_X] in 1 mL
tussilago farfaraActive
Code: 0JXZ63016VClass: ACTIBQuantity: 15 [hp_X] in 1 mL
verbascum thapsusActive
Code: C9TD27U172Class: ACTIBQuantity: 15 [hp_X] in 1 mL
EchinaceaActive
Code: 4N9P6CC1DXClass: ACTIBQuantity: 6 [hp_X] in 1 mL
Code: DL6OZ476V3Class: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: S7V92P67HOClass: ACTIBQuantity: 15 [hp_X] in 1 mL
chelidonium majusActive
Code: 7E889U5RNNClass: ACTIBQuantity: 15 [hp_X] in 1 mL
cinchona officinalis barkActive
Code: S003A158SBClass: ACTIBQuantity: 15 [hp_X] in 1 mL
drosera anglicaActive
Code: J61BY05EGYClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 72T9EZC2VXClass: ACTIBQuantity: 15 [hp_X] in 1 mL
HistamineActive
Code: 3POA0Q644UClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: ZW3Z11D0JVClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: BQN1B9B9HAClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 1C4QK22F9JClass: ACTIMQuantity: 15 [hp_X] in 1 mL
MyrrhActive
Code: JC71GJ1F3LClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 0YPR65R21JClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 27YLU75U4WClass: ACTIBQuantity: 15 [hp_X] in 1 mL
anemone pulsatillaActive
Code: I76KB35JEVClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: CT03BSA18UClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 269XH13919Class: ACTIBQuantity: 15 [hp_X] in 1 mL
PotassiumActive
Code: T4423S18FMClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 9N1RM2S62CClass: ACTIBQuantity: 15 [hp_X] in 1 mL
Code: 1314JZ2X6WClass: ACTIBQuantity: 30 [hp_X] in 1 mL
Code: R9HH0NDE2EClass: ACTIBQuantity: 30 [hp_X] in 1 mL
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