FDA.reportPublic FDA data

LUMOe WELL Respiratory Relief

Product NDC
81425-005
11-digit product format
814250005
Labeler code
81425
Product ID
81425-005_ebcdc75a-a6b6-4429-a70e-3b966a01bf07
Type
HUMAN OTC DRUG
Nonproprietary name
Crotalus horridus, Sticta pulmonaria, Viola odorata
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Applied Bioenergetics, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-09-27
Substance
CROTALUS HORRIDUS HORRIDUS VENOM; LOBARIA PULMONARIA; VIOLA ODORATA
Active strength
30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LUMOe WELL Respiratory Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CROTALUS HORRIDUS HORRIDUS VENOM30 [hp_X]/1
LOBARIA PULMONARIA30 [hp_X]/1
VIOLA ODORATA30 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYHA2XLJ956, D1YM0P5Z2T, AET12U8B74

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81425-005-10LUMOe WELL Respiratory Relief180 in 1 BOTTLETABLET, CHEWABLE1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81425-005LUMOE WELL RESPIRATORY RELIEF (CROTALUS HORRIDUS, STICTA PULMONARIA, VIOLA ODORATA) TABLET, CHEWABLE [APPLIED BIOENERGETICS, LLC]2Current NDC, 1 package rows20241003_b043d612-82e1-45a2-8761-89c4c8046c62.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81425-005-1081425000510180 TABLET, CHEWABLE in 1 BOTTLE (81425-005-10) 2024-09-27NoNoCurrent