FDA.reportPublic FDA data

Smogstat

Product NDC
44911-0561
11-digit product format
449110561
Labeler code
44911
Product ID
44911-0561_2b8a5a14-8b73-4b7c-b5ea-94d15ce02e1b
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea (Angustifolia), Hypericum Perforatum, Hydrastis Canadensis, Symphytum Officinale, Arsenicum Album, Carbo Vegetabilis, Causticum, Kali Carbonicum, Natrum Sulphuricum, Phosphorus, Pulsatilla (Pratensis), Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-07
Substance
ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CAUSTICUM; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; HYPERICUM PERFORATUM WHOLE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; SODIUM SULFATE
Active strength
12; 12; 12; 6; 3; 6; 3; 12; 12; 12; 12; 12 [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; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTIVATED CHARCOAL12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
CAUSTICUM12 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE3 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
POTASSIUM CARBONATE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2P3VWU3H10, S7V92P67HO, DD5FO1WKFU, M9VVZ08EKQ, VB06AV5US8, ZW3Z11D0JV, XK4IUX8MNB, 27YLU75U4W, BQN1B9B9HA, 8E272251DI, ETJ7Z6XBU4, 0YPR65R21J

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
44911-0561-12024-07-25C16284748780-1d6a99b39-e8df-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0561-12022-01-28C16284748780-1d6a99b39-e8df-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0561-1Smogstat30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0561SMOGSTAT (ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240726_59f63e2b-24fa-43a0-8334-02e6729c6ac1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0561-14491105610130 mL in 1 BOTTLE, DROPPER (44911-0561-1) 30 ml2020-12-070000-00-00NoNoCurrent