Regen

Product NDC
44911-0529
Requested package NDC
44911-0529-1
11-digit product format
449110529
Labeler code
44911
Product ID
44911-0529_64b5cb96-6e00-4e4f-b270-24f1619db3d1
Type
HUMAN OTC DRUG
Nonproprietary name
Cinnamomum, Echinacea (Angustifolia), Hydrastis Canadensis, Lappa Major, Trifolium Pratense
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-24
Marketing end
2027-10-21
Substance
CINNAMON; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; ARCTIUM LAPPA ROOT; TRIFOLIUM PRATENSE FLOWER
Active strength
12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]
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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…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
Regen
Brand name suffix
HP

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINNAMON12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE12 [hp_X]/mL
GOLDENSEAL12 [hp_X]/mL
ARCTIUM LAPPA ROOT12 [hp_X]/mL
TRIFOLIUM PRATENSE FLOWER12 [hp_X]/mL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-03DRUG FACTS:
2024-07-03DRUG FACTS:
2022-01-28DRUG FACTS:
2022-01-28DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0529-1RegenHP60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0529REGEN HP (CINNAMOMUM, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LAPPA MAJOR, TRIFOLIUM PRATENSE) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240704_6c796f64-29a0-4e87-871a-88fbeb7a1d61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0529-14491105290160 mL in 1 BOTTLE, DROPPER (44911-0529-1) 60 ml2020-02-242027-10-21NoNoCurrent