FDA.reportPublic FDA data

Breathtone

Product NDC
44911-0590
11-digit product format
449110590
Labeler code
44911
Product ID
44911-0590_f5157189-1447-4dd3-b342-0c14ccaffcef
Type
HUMAN OTC DRUG
Nonproprietary name
Lobelia Inflata, Verbascum Thapsus, Balsamum Peruvianum, Antimonium Tartaricum, Arsenicum Album, Drosera (Rotundifolia), Kali Bichromicum, Kali Carbonicum, Natrum Sulphuricum, Phosphorous, Spongia Tosta
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-05-27
Substance
ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BALSAM PERU; DROSERA ROTUNDIFOLIA WHOLE; LOBELIA INFLATA WHOLE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS WHOLE
Active strength
12; 12; 6; 12; 3; 12; 12; 12; 12; 12; 3 [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; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Breathtone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY POTASSIUM TARTRATE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BALSAM PERU6 [hp_X]/mL
DROSERA ROTUNDIFOLIA WHOLE12 [hp_X]/mL
LOBELIA INFLATA WHOLE3 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
POTASSIUM CARBONATE12 [hp_X]/mL
POTASSIUM DICHROMATE12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED12 [hp_X]/mL
VERBASCUM THAPSUS WHOLE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDL6OZ476V3, S7V92P67HO, 8P5F881OCY, QR44N9XPJQ, 9PP1T3TC5U, 27YLU75U4W, BQN1B9B9HA, T4423S18FM, 0YPR65R21J, 1PIP394IID, C9TD27U172

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0590-12023-08-14C16284748780-1f386c649-b0b8-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0590-12023-01-30C16284748780-1f386c649-b0b8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0590-1Breathtone30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0590BREATHTONE (LOBELIA INFLATA, VERBASCUM THAPSUS, BALSAMUM PERUVIANUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHOROUS, SPONGIA TOSTA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20230815_c388da29-824a-41a5-be85-47a60bccf3da.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0590-14491105900130 mL in 1 BOTTLE, DROPPER (44911-0590-1) 30 ml2021-05-270000-00-00NoNoCurrent