Additivestat

Product NDC
44911-0630
11-digit product format
449110630
Labeler code
44911
Product ID
44911-0630_91797091-444c-4929-9521-0587fa291c89
Type
HUMAN OTC DRUG
Nonproprietary name
Trifolium Pratense, Petroleum, Phytolacca Decandra, Arsenicum Album, Chelidonium Majus, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Nitricum Acidum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-30
Substance
TRIFOLIUM PRATENSE FLOWER; KEROSENE; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS WHOLE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; NITRIC ACID
Active strength
3; 6; 6; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 8 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 packagepackage44911-0630-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage44911-0630-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage44911-0630-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-0630-11332a3947898…d4bfe170f9cd…

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
Additivestat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFOLIUM PRATENSE FLOWER3 [hp_X]/mL
KEROSENE6 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
NITRIC ACID12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4JS0838828Internal UNII lookup
1C89KKC04EInternal UNII lookup
11E6VI8VEGInternal UNII lookup
S7V92P67HOInternal UNII lookup
7E889U5RNNInternal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
E4GA8884NNInternal UNII lookup
27YLU75U4WInternal UNII lookup
411VRN1TV4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a9490c2-1fdb-43b4-aeae-6e783b333f03Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0630-12024-07-16C16284748780-11030e365-3321-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0630-12024-01-30C16284748780-11030e365-3321-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0630-1Additivestat30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0630ADDITIVESTAT (TRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240718_8a9490c2-1fdb-43b4-aeae-6e783b333f03.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
AdditivestatTRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUMEnergique, Inc.8a9490c2-1fdb-43b4-aeae-6e783b333f032024-07-16WarningsExact identifier
ndc (product): 44911-0630

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0630-14491106300130 mL in 1 BOTTLE, DROPPER (44911-0630-1) 30 ml2020-12-300000-00-00NoNoCurrent