FDA.reportPublic FDA data

BM HOMEOPATHIC REMEDY BIO COM 23 TOOTHACHE

Manufacturer
BM Private Limited
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:37:34

Label at a glance#

ProductBM HOMEOPATHIC REMEDY BIO COM 23 TOOTHACHE
Active ingredientCALCIUM FLUORIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Dosage:
Adults: Four tablets three times a day.
Children: half of the same or as advised by a homeopathic physician.

OTC - ACTIVE INGREDIENT SECTION

Mag phos, calc fluor, ferr phos

INACTIVE INGREDIENT SECTION

LACTOSE, MAGNESIUM STEARATE

INDICATIONS & USAGE SECTION

See the enclosed detail for detail

OTC - PURPOSE SECTION

For detail, please read the enclosed package (product information leaflet)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Precautions/storage:
Keep away from children and store at cool and dry place.

WARNINGS SECTION

Precautions/storage:
Keep away from children and store at cool and dry place.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package 1:

BIO 23.jpgBIO 23.jpg

Package 2:

Bio combination 23Bio combination 23

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
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efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-3023-1BM HOMEOPATHIC REMEDY BIO COM 23 TOOTHACHE30 g in 1 BOTTLE, GLASSGLOBULE302
85816-3023-2BM HOMEOPATHIC REMEDY BIO COM 23 TOOTHACHE500 g in 1 BOTTLE, GLASSGLOBULE5002

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85816-302385816-3023-1, 85816-3023-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB

Source Document#

Source XML

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
BM HOMEOPATHIC REMEDY BIO COM 23 TOOTHACHECALC FLUOR, FERR PHOS, MAG PHOSBM Private Limited3b2a75d0-49a1-d6fe-e063-6394a90a43d02026-02-12WarningsExact identifier
ndc (package): 85816-3023-1
ndc (package): 85816-3023-2
ndc (product): 85816-3023
ndc11 (package): 85816302301
ndc11 (package): 85816302302
spl id: 4aa081c5-ac47-4951-e063-6394a90a18b3
spl set id: 3b2a75d0-49a1-d6fe-e063-6394a90a43d0

Reported adverse events (FAERS/openFDA)#

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