Smogstat

Product NDC
44911-0561
11-digit product format
449110561
Labeler code
44911
Product ID
44911-0561_be981945-ca6c-4ba9-8f20-256436d9e078
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
Marketing end
2029-07-21
Substance
ECHINACEA ANGUSTIFOLIA WHOLE; HYPERICUM PERFORATUM WHOLE; GOLDENSEAL; COMFREY ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; CAUSTICUM; POTASSIUM CARBONATE; SODIUM SULFATE; PHOSPHORUS; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE
Active strength
3; 3; 6; 6; 12; 12; 12; 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
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44911-0561-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0561-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0561-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0561-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage44911-0561-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage44911-0561-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage44911-0561-1bd6a592717d7…303034d00443…

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
Smogstat

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB06AV5US8Internal UNII lookup
XK4IUX8MNBInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
S7V92P67HOInternal UNII lookup
2P3VWU3H10Internal UNII lookup
DD5FO1WKFUInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
0YPR65R21JInternal UNII lookup
27YLU75U4WInternal UNII lookup
8E272251DIInternal 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
59f63e2b-24fa-43a0-8334-02e6729c6ac1Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-07-25DRUG FACTS:
2024-07-25DRUG FACTS:
2022-01-28DRUG FACTS:
2022-01-28DRUG 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

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
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
ndc (product): 44911-0561

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 ml2020-12-072029-07-21NoNoCurrent