FDA.reportPublic FDA data

Burn Aide

Product NDC
43857-0472
11-digit product format
438570472
Labeler code
43857
Product ID
43857-0472_f24eeb11-c61d-41d2-bb03-e55ed99fe554
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Picricum Acidum, Urtica Urens
Dosage form
SPRAY
Route
TOPICAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-03-13
Substance
ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; HYPERICUM PERFORATUM WHOLE; LYTTA VESICATORIA; PICRIC ACID; URTICA URENS WHOLE
Active strength
12; 12; 1; 12; 1; 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
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
URTICA URENS WHOLE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, WQZ3G9PF0H, 18E7415PXQ, DD5FO1WKFU, XK4IUX8MNB, 3Q034RO3BT, A49OS0F91S, 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
43857-0472-12024-10-22C16284748780-1ba0f9c33-1e7a-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0472-12021-01-29C16284748780-1ba0f9c33-1e7a-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0472-1Burn Aide120 mL in 1 BOTTLE, SPRAYSPRAY1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0472BURN AIDE (CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, ARSENICUM ALBUM, BELLADONNA, CANTHARIS, CAUSTICUM, PICRICUM ACIDUM, URTICA URENS) SPRAY [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20241024_66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0472-143857047201120 mL in 1 BOTTLE, SPRAY (43857-0472-1) 120 ml2018-03-13NoNoHistorical