FDA.reportPublic FDA data

Bac

Product NDC
81825-0013
11-digit product format
818250013
Labeler code
81825
Product ID
81825-0013_e436e29b-cd00-484e-81a1-d18f67b5f850
Type
HUMAN OTC DRUG
Nonproprietary name
apis mellifera, arsenic trioxide, atropa belladonna, matricaria chamomilla flowering top oil, lachesis muta venom, mercurius solubilis, pulsatilla vulgaris whole, toxicodendron pubescens leaf, and silicon dioxide
Dosage form
LIQUID
Route
ORAL
Labeler
Zorex
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-06-26
Substance
APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30 [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
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [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
Bac
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA30 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
ATROPA BELLADONNA30 [hp_X]/mL
MATRICARIA CHAMOMILLA FLOWERING TOP OIL30 [hp_X]/mL
LACHESIS MUTA VENOM30 [hp_X]/mL
MERCURIUS SOLUBILIS30 [hp_X]/mL
PULSATILLA VULGARIS WHOLE30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF30 [hp_X]/mL
SILICON DIOXIDE30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
SA8AR2W4ERInternal UNII lookup
VSW71SS07IInternal UNII lookup
324Y4038G2Internal UNII lookup
I76KB35JEVInternal UNII lookup
6IO182RP7AInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ae38e0c-8e74-4fd5-8605-45e424a84d01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0013-1Bac30 mL in 1 BOTTLE, DROPPERLIQUID301

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
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
ndc (product): 81825-0013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81825-0013-18182500130130 mL in 1 BOTTLE, DROPPER (81825-0013-1) 30 ml2025-06-26NoNoCurrent