FDA.reportPublic FDA data

HKI

Product NDC
62106-0625
11-digit product format
621060625
Labeler code
62106
Product ID
62106-0625_f38e873c-cc3c-f701-e053-2a95a90af213
Type
HUMAN OTC DRUG
Nonproprietary name
Atropinum sulphuricum, Benzoicum acidum, Berberis vulgaris, Calcarea carbonica, Colocynthis, Coccus cacti, Lapis albus, Lithium carbonicum, Lycopodium clavatum, Oryctolagus cuniculus kidney, Rubia tinctorum, Sarsaparilla, Urtica urens
Dosage form
LIQUID
Route
SUBLINGUAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-12-14
Substance
ATROPINE SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; ORYCTOLAGUS CUNICULUS KIDNEY; SARSAPARILLA; CALCIUM HEXAFLUOROSILICATE; BENZOIC ACID; PROTORTONIA CACTI; LITHIUM CARBONATE; RUBIA TINCTORUM ROOT; URTICA URENS; BERBERIS VULGARIS ROOT BARK
Active strength
6; 12; 6; 5; 10; 1; 12; 6; 5; 6; 4; 1; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Mood Stabilizer [EPC], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
HKI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE6 [hp_X]/30mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/30mL
CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]/30mL
LYCOPODIUM CLAVATUM SPORE5 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS KIDNEY10 [hp_X]/30mL
SARSAPARILLA1 [hp_X]/30mL
CALCIUM HEXAFLUOROSILICATE12 [hp_C]/30mL
BENZOIC ACID6 [hp_X]/30mL
PROTORTONIA CACTI5 [hp_X]/30mL
LITHIUM CARBONATE6 [hp_X]/30mL
RUBIA TINCTORUM ROOT4 [hp_X]/30mL
URTICA URENS1 [hp_X]/30mL
BERBERIS VULGARIS ROOT BARK5 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03J5ZE7KA5Internal UNII lookup
2E32821G6IInternal UNII lookup
23H32AOH17Internal UNII lookup
C88X29Y479Internal UNII lookup
482QQ7H44QInternal UNII lookup
2H1576D5WGInternal UNII lookup
2NVP93XVQ3Internal UNII lookup
8SKN0B0MIMInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
2BMD2GNA4VInternal UNII lookup
0SVP95L23GInternal UNII lookup
IHN2NQ5OF9Internal UNII lookup
1TH8Q20J0UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26e048f5-8e87-51e6-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-0625-0HKI30 mL in 1 BOTTLE, GLASSLIQUID305
62106-0625-0HKI1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-0625HKI (ATROPINUM SULPHURICUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, CALCAREA CARBONICA, COLOCYNTHIS, COCCUS CACTI, LAPIS ALBUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, ORYCTOLAGUS CUNICULUS KIDNEY, RUBIA TINCTORUM, SARSAPARILLA, URTICA URENS) LIQUID [SEROYAL USA]5Current NDC, Legacy NDC, 2 package rows20230201_26e048f5-8e87-51e6-e054-00144ff88e88.zip

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
HKIATROPINUM SULPHURICUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, CALCAREA CARBONICA, COLOCYNTHIS, COCCUS CACTI, LAPIS ALBUS, LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, ORYCTOLAGUS CUNICULUS KIDNEY, RUBIA TINCTORUM, SARSAPARILLA, URTICA URENSSeroyal USA26e048f5-8e87-51e6-e054-00144ff88e882023-01-31WarningsExact identifier
ndc (product): 62106-0625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-0625-0621060625001 BOTTLE, GLASS in 1 CARTON (62106-0625-0) / 30 mL in 1 BOTTLE, GLASS2015-12-140000-00-00NoNoCurrent