ALEROFF- histamine liquid
OKSALUD COLOMBIA S A S

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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ALEROFF
histamine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81701-111
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HISTAMINE (UNII: 820484N8I3) (HISTAMINE - UNII:820484N8I3)	HISTAMINE	7 g in 7 mL

Ingredient Name	Strength
Inactive Ingredients
TUSSILAGO FARFARA FLOWER (UNII: UEE27X2Q2M)	7 mL in 7 mL
ALCOHOL (UNII: 3K9958V90M)	7 mL in 7 mL
CALADIUM BICOLOR WHOLE (UNII: 66BMR064Z9)	7 mL in 7 mL
RANUNCULUS BULBOSUS ROOT (UNII: XV11P9Y1A1)	7 mL in 7 mL
URTICA DIOICA (UNII: 710FLW4U46)	7 mL in 7 mL
SOLANUM LYCOPERSICUM WHOLE (UNII: 0243Q4990L)	7 mL in 7 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81701-111-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2021

Labeler - OKSALUD COLOMBIA S A S (885622207)

Registrant - OKSALUD COLOMBIA S A S (885622207)

Name	Address	ID/FEI	Business Operations
Establishment
OKSALUD COLOMBIA S A S		885622207	manufacture(81701-111) , label(81701-111)