FDA.reportPublic FDA data

Thyropar

Product NDC
44911-0535
11-digit product format
449110535
Labeler code
44911
Product ID
44911-0535_1387214b-6ef9-4562-aa90-3a7c31bd7c61
Type
HUMAN OTC DRUG
Nonproprietary name
Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (Suis), Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (Pratensis)
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-03-02
Marketing end
2026-12-07
Substance
ANEMONE PRATENSIS; BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID
Active strength
12; 12; 3; 12; 12; 12; 3; 6; 6; 6 [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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage44911-0535-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage44911-0535-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage44911-0535-1bd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Thyropar

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FUCUS VESICULOSUS12 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED12 [hp_X]/mL
SUS SCROFA ADRENAL GLAND3 [hp_X]/mL
SUS SCROFA PITUITARY GLAND12 [hp_X]/mL
SUS SCROFA THYROID12 [hp_X]/mL
BROMINE12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]/mL
IODINE6 [hp_X]/mL
LACHESIS MUTA VENOM6 [hp_X]/mL
ANEMONE PRATENSIS6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
535G2ABX9MInternal UNII lookup
1PIP394IIDInternal UNII lookup
398IYQ16YVInternal UNII lookup
L0PFEMQ1DTInternal UNII lookup
6RV024OAUQInternal UNII lookup
SBV4XY874GInternal UNII lookup
2E32821G6IInternal UNII lookup
9679TC07X4Internal UNII lookup
VSW71SS07IInternal UNII lookup
8E272251DIInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9482ff15-15b2-4c1f-ae15-24f6d810254eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0535-12023-10-30C16284748780-1d6a99b39-87ab-a426-e053-dadaa90af4c2Drug Facts:
44911-0535-12022-01-28C16284748780-1d6a99b39-87ab-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0535-1Thyropar30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0535THYROPAR (FUCUS VESICULOSUS, SPONGIA TOSTA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), BROMIUM, CALCAREA CARBONICA, IODIUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS)) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20231031_9482ff15-15b2-4c1f-ae15-24f6d810254e.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
ThyroparFUCUS VESICULOSUS, SPONGIA TOSTA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), BROMIUM, CALCAREA CARBONICA, IODIUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS)Energique, Inc.9482ff15-15b2-4c1f-ae15-24f6d810254e2023-10-30WarningsExact identifier
ndc (product): 44911-0535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0535-14491105350130 mL in 1 BOTTLE, DROPPER (44911-0535-1) 30 ml2020-03-022026-12-07NoNoCurrent