FDA.reportPublic FDA data

Skin Irritant and Healing Support

Product NDC
43846-0046
Requested package NDC
43846-0046-1
11-digit product format
438460046
Labeler code
43846
Product ID
43846-0046_2e6905c8-6208-4e01-a23c-89605ac7818d
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii)
Dosage form
SPRAY
Route
TOPICAL
Labeler
Peaceful Mountain, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-07
Marketing end
2022-02-24
Substance
CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA
Active strength
12 [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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43846-004643846-0046-1DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0046-12021-12-14C16284748780-19d75b9d0-b182-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0046-12020-01-31C16284748780-19d75b9d0-b182-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CROTON TIGLIUM SEEDACTIVE INGREDIENT0HK2GZK66ESKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6USKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SARSAPARILLAACTIVE INGREDIENT2H1576D5WGSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ASKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CHLORIDE IONACTIVE MOIETYQ32ZN48698SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CROTON TIGLIUM SEEDACTIVE MOIETY0HK2GZK66ESKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PLANTAGO MAJORACTIVE MOIETYW2469WNO6USKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SARSAPARILLAACTIVE MOIETY2H1576D5WGSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ASKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEASKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438USKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
CROTON LECHLERI RESININACTIVE INGREDIENTGGG6W25C63SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
EGG SHELL MEMBRANEINACTIVE INGREDIENTN7QBR4212VSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNBSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049PSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
LECITHIN, SUNFLOWERINACTIVE INGREDIENT834K0WOS5GSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE63661499SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEGSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ASKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SILVERINACTIVE INGREDIENT3M4G523W1GSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2
WHEYINACTIVE INGREDIENT8617Z5FMF6SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43846-0046-14384600460130 mL in 1 BOTTLE, SPRAY (43846-0046-1) 30 ml2015-01-072022-02-24NoNoCurrent