FDA.reportPublic FDA data

BM BM36

Product NDC
85816-7036
11-digit product format
858167036
Labeler code
85816
Product ID
85816-7036_51740fae-b339-074f-e063-6394a90aed37
Type
HUMAN OTC DRUG
Nonproprietary name
Calc Carb, Calc Fluor, Cistus Can, Fraxinus, Fucus Ves, Oophor, Secale Corn, Thuja occ
Dosage form
GLOBULE
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-01-01
Substance
CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; CROCANTHEMUM CANADENSE; FRAXINUS AMERICANA BARK; FUCUS VESICULOSUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
12; 3; 10; 3; 4; 16; 16; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BM BM36
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE12 [hp_X]/g
CLAVICEPS PURPUREA SCLEROTIUM3 [hp_X]/g
CROCANTHEMUM CANADENSE10 [hp_X]/g
FRAXINUS AMERICANA BARK3 [hp_X]/g
FUCUS VESICULOSUS4 [hp_X]/g
OYSTER SHELL CALCIUM CARBONATE, CRUDE16 [hp_X]/g
SUS SCROFA OVARY16 [hp_X]/g
THUJA OCCIDENTALIS LEAFY TWIG4 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3B55K4YKI, 01G9XEA93N, 46G3W789Q3, 0B24UR1O1S, 535G2ABX9M, 2E32821G6I, S7YTV04R8O, 1NT28V9397

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-7036-1BM BM3625 g in 1 BOTTLE, GLASSGLOBULE252
85816-7036-2BM BM36500 g in 1 JARGLOBULE5002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-7036-18581670360125 g in 1 BOTTLE, GLASS (85816-7036-1) 25 g2025-01-01NoNoHistorical
85816-7036-285816703602500 g in 1 JAR (85816-7036-2) 500 g2025-01-01NoNoHistorical