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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
Sodium sulfate(15 [hp_X] in 1 g)
Phosphorus(15 [hp_X] in 1 g)
anemone pulsatilla(15 [hp_X] in 1 g)
Nux vomica extract(15 [hp_X] in 1 g)
Rumex crispus whole(15 [hp_X] in 1 g)
spongia officinalis skeleton, roasted(15 [hp_X] in 1 g)
tussilago farfara(15 [hp_X] in 1 g)
Antimony potassium tartrate(15 [hp_X] in 1 g)
Arsenic trioxide(15 [hp_X] in 1 g)
bryonia alba root(15 [hp_X] in 1 g)
chelidonium majus(15 [hp_X] in 1 g)
cinchona officinalis bark(15 [hp_X] in 1 g)
drosera anglica(15 [hp_X] in 1 g)
Eucalyptus gum(15 [hp_X] in 1 g)
Histamine(15 [hp_X] in 1 g)
Goldenseal(15 [hp_X] in 1 g)
Potassium carbonate(15 [hp_X] in 1 g)
Potassium Iodide(15 [hp_X] in 1 g)
Myrrh(15 [hp_X] in 1 g)
verbascum thapsus(15 [hp_X] in 1 g)
Echinacea(6 [hp_X] in 1 g)
arctium lappa root(6 [hp_X] in 1 g)
Potassium(15 [hp_X] in 1 g)

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
55714-1736
Route of Administration
ORAL
Effective Date
May 7, 2025
Code: 0YPR65R21JClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 27YLU75U4WClass: ACTIBQuantity: 15 [hp_X] in 1 g
anemone pulsatillaActive
Code: I76KB35JEVClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 269XH13919Class: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 9N1RM2S62CClass: ACTIBQuantity: 15 [hp_X] in 1 g
spongia officinalis skeleton, roastedActive
Code: 1PIP394IIDClass: ACTIBQuantity: 15 [hp_X] in 1 g
tussilago farfaraActive
Code: 0JXZ63016VClass: ACTIBQuantity: 15 [hp_X] in 1 g
SUCROSEInactive
Code: C151H8M554Class: IACT
Code: CT03BSA18UClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: DL6OZ476V3Class: ACTIBQuantity: 15 [hp_X] in 1 g
Code: S7V92P67HOClass: ACTIBQuantity: 15 [hp_X] in 1 g
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 15 [hp_X] in 1 g
chelidonium majusActive
Code: 7E889U5RNNClass: ACTIBQuantity: 15 [hp_X] in 1 g
cinchona officinalis barkActive
Code: S003A158SBClass: ACTIBQuantity: 15 [hp_X] in 1 g
drosera anglicaActive
Code: J61BY05EGYClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 72T9EZC2VXClass: ACTIBQuantity: 15 [hp_X] in 1 g
HistamineActive
Code: 3POA0Q644UClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: ZW3Z11D0JVClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: BQN1B9B9HAClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 1C4QK22F9JClass: ACTIMQuantity: 15 [hp_X] in 1 g
MyrrhActive
Code: JC71GJ1F3LClass: ACTIBQuantity: 15 [hp_X] in 1 g
verbascum thapsusActive
Code: C9TD27U172Class: ACTIBQuantity: 15 [hp_X] in 1 g
EchinaceaActive
Code: 4N9P6CC1DXClass: ACTIBQuantity: 6 [hp_X] in 1 g
arctium lappa rootActive
Code: 597E9BI3Z3Class: ACTIBQuantity: 6 [hp_X] in 1 g
PotassiumActive
Code: T4423S18FMClass: ACTIBQuantity: 15 [hp_X] in 1 g
Code: 1314JZ2X6WClass: ACTIBQuantity: 30 [hp_X] in 1 g
Code: R9HH0NDE2EClass: ACTIBQuantity: 30 [hp_X] in 1 g
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