FDA.reportPublic FDA data

KREOSOTE

Product NDC
85816-2227
11-digit product format
858162227
Labeler code
85816
Product ID
85816-2227_4ae55c0e-3e9a-703b-e063-6394a90a345a
Type
HUMAN OTC DRUG
Nonproprietary name
acid nit, belladonna, borax, chamomilla, kreosote, merc sol, staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
ATROPA BELLADONNA; CHAMOMILE; DELPHINIUM STAPHISAGRIA SEED; MERCURIUS SOLUBILIS; NITRIC ACID; SODIUM BORATE; WOOD CREOSOTE
Active strength
7; 7; 7; 10; 7; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KREOSOTE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA7 [hp_X]/mL
CHAMOMILE7 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED7 [hp_X]/mL
MERCURIUS SOLUBILIS10 [hp_X]/mL
NITRIC ACID7 [hp_X]/mL
SODIUM BORATE7 [hp_X]/mL
WOOD CREOSOTE7 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWQZ3G9PF0H, FGL3685T2X, 00543AP1JV, 324Y4038G2, 411VRN1TV4, 91MBZ8H3QO, 3JYG22FD73

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-2227-1KREOSOTE30 mL in 1 BOTTLE, GLASSLIQUID302
85816-2227-2KREOSOTE500 mL in 1 BOTTLE, GLASSLIQUID5002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2227-18581622270130 mL in 1 BOTTLE, GLASS (85816-2227-1) 30 ml2015-01-01NoNoHistorical
85816-2227-285816222702500 mL in 1 BOTTLE, GLASS (85816-2227-2) 500 ml2015-01-01NoNoHistorical