FDA.reportPublic FDA data

AKSO N2

Product NDC
43853-0099
11-digit product format
438530099
Labeler code
43853
Product ID
43853-0099_50284424-d8d2-d2dc-e063-6394a90ab84c
Type
HUMAN OTC DRUG
Nonproprietary name
Arginine pyroglutamate, Coleus forskohlii, Glutamine, Glycine, Mucuna pruriens, Ornithine alpha-ketoglutarate, Dioscorea villosa, Tyrosine
Dosage form
SPRAY
Route
TOPICAL
Labeler
HEALWAY
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-12-22
Substance
ARGININE PYROGLUTAMATE; TYROSINE; DIOSCOREA VILLOSA ROOT; ORNITHINE OXOGLURATE; MUCUNA PRURIENS SEED; LYSINE; GLYCINE; GLUTAMINE; COLEUS FORSKOHLII ROOT OIL
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
AKSO N2
Brand name suffix
Youth Complex Essence
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARGININE PYROGLUTAMATE12 [hp_X]/mL
TYROSINE12 [hp_X]/mL
DIOSCOREA VILLOSA ROOT12 [hp_X]/mL
ORNITHINE OXOGLURATE12 [hp_X]/mL
MUCUNA PRURIENS SEED12 [hp_X]/mL
LYSINE12 [hp_X]/mL
GLYCINE12 [hp_X]/mL
GLUTAMINE12 [hp_X]/mL
COLEUS FORSKOHLII ROOT OIL12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808T94CEU6Internal UNII lookup
42HK56048UInternal UNII lookup
IWY3IWX2G8Internal UNII lookup
4FEN49K96WInternal UNII lookup
55G8SQ543SInternal UNII lookup
K3Z4F929H6Internal UNII lookup
TE7660XO1CInternal UNII lookup
0RH81L854JInternal UNII lookup
5NXR7DJ9WOInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5028304b-22b4-c191-e063-6394a90a5525Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73df98bc-429f-4587-8299-6ad8d52a4f36Product name220250304
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0099-1AKSO N2Youth Complex Essence59 mL in 1 BOTTLE, SPRAYSPRAY591

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AKSO N2 Youth Complex EssenceARGININE PYROGLUTAMATE, COLEUS FORSKOHLII, GLUTAMINE, GLYCINE, MUCUNA PRURIENS, ORNITHINE ALPHA-KETOGLUTARATE, DIOSCOREA VILLOSA, TYROSINEHEALWAY5028304b-22b4-c191-e063-6394a90a55252026-04-23WarningsExact identifier
ndc (product): 43853-0099

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43853-0099-14385300990159 mL in 1 BOTTLE, SPRAY (43853-0099-1) 59 ml2026-04-23NoNoCurrent