FDA.reportPublic FDA data

Burn Aide

Product NDC
44911-0662
11-digit product format
449110662
Labeler code
44911
Product ID
44911-0662_a3fb5283-fe75-46e1-bb7a-d29e7b78ec97
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Kali Bichromicum, Picricum Acidum, Urtica Urens
Dosage form
SPRAY
Route
TOPICAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-11-18
Substance
ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; HYPERICUM PERFORATUM WHOLE; LYTTA VESICATORIA; PICRIC ACID; POTASSIUM DICHROMATE; URTICA URENS WHOLE
Active strength
12; 12; 1; 12; 1; 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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Aide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/mL
ATROPA BELLADONNA12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/mL
CAUSTICUM12 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE1 [hp_X]/mL
LYTTA VESICATORIA12 [hp_X]/mL
PICRIC ACID12 [hp_X]/mL
POTASSIUM DICHROMATE12 [hp_X]/mL
URTICA URENS WHOLE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, WQZ3G9PF0H, 18E7415PXQ, DD5FO1WKFU, XK4IUX8MNB, 3Q034RO3BT, A49OS0F91S, T4423S18FM, IHN2NQ5OF9

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
44911-0662-12024-08-05C16284748780-11030e365-60b1-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0662-12024-01-30C16284748780-11030e365-60b1-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0662-1Burn Aide180 mL in 1 BOTTLE, SPRAYSPRAY1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0662BURN AIDE (CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, KALI BICHROMICUM, PICRICUM ACIDUM, URTICA URENS) SPRAY [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240806_62ce13b1-ca8d-4d6b-932d-db13a816bc37.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0662-144911066201180 mL in 1 BOTTLE, SPRAY (44911-0662-1) 180 ml2022-11-180000-00-00NoNoCurrent