Home NDC 43846-0046 Skin Irritant and Healing Support
Product NDC 43846-0046
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 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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43846-0046-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43846-0046-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43846-0046-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43846-0046-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43846-0046-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43846-0046-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43846-0046-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43846-0046-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43846-0046-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43846-0046-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43846-0046-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43846-0046-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43846-0046-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43846-0046-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALENDULA OFFICINALIS FLOWERING TOP ACTIVE INGREDIENT 18E7415PXQ SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 CROTON TIGLIUM SEED ACTIVE INGREDIENT 0HK2GZK66E SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PLANTAGO MAJOR ACTIVE INGREDIENT W2469WNO6U SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SARSAPARILLA ACTIVE INGREDIENT 2H1576D5WG SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SODIUM CHLORIDE ACTIVE INGREDIENT 451W47IQ8X SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 TOXICODENDRON PUBESCENS LEAF ACTIVE INGREDIENT 6IO182RP7A SKIN 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 TOP ACTIVE MOIETY 18E7415PXQ SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 CHLORIDE ION ACTIVE MOIETY Q32ZN48698 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 CROTON TIGLIUM SEED ACTIVE MOIETY 0HK2GZK66E SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PLANTAGO MAJOR ACTIVE MOIETY W2469WNO6U SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SARSAPARILLA ACTIVE MOIETY 2H1576D5WG SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 TOXICODENDRON PUBESCENS LEAF ACTIVE MOIETY 6IO182RP7A SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 ACHILLEA MILLEFOLIUM FLOWER INACTIVE INGREDIENT YQR8R0SQEA SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 ARNICA MONTANA FLOWER INACTIVE INGREDIENT OZ0E5Y15PZ SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 COMFREY LEAF INACTIVE INGREDIENT DG4F8T839X SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 CROTON LECHLERI RESIN INACTIVE INGREDIENT GGG6W25C63 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 EGG SHELL MEMBRANE INACTIVE INGREDIENT N7QBR4212V SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 HYPERICUM PERFORATUM INACTIVE INGREDIENT XK4IUX8MNB SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 LARREA TRIDENTATA TOP INACTIVE INGREDIENT PK0TXD049P SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 LAVANDULA ANGUSTIFOLIA FLOWER INACTIVE INGREDIENT 19AH1RAF4M SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 LECITHIN, SUNFLOWER INACTIVE INGREDIENT 834K0WOS5G SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 MELISSA OFFICINALIS LEAF INACTIVE INGREDIENT 50D2ZE9219 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PEG-8 DIMETHICONE INACTIVE INGREDIENT GIA7T764OD SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PHYTOLACCA AMERICANA FRUIT INACTIVE INGREDIENT WE63661499 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 PHYTOLACCA AMERICANA ROOT INACTIVE INGREDIENT 11E6VI8VEG SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 POLYETHYLENE GLYCOL 700 INACTIVE INGREDIENT 762678AC5R SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SALIX ALBA BARK INACTIVE INGREDIENT 205MXS71H7 SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SILVER INACTIVE INGREDIENT 3M4G523W1G SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 SORBIC ACID INACTIVE INGREDIENT X045WJ989B SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SKIN IRRITANT AND HEALING SUPPORT (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [PEACEFUL MOUNTAIN, INC.] 2 WHEY INACTIVE INGREDIENT 8617Z5FMF6 SKIN 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 NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43846-0046-1 43846004601 30 mL in 1 BOTTLE, SPRAY (43846-0046-1) 30 ml 2015-01-07 2022-02-24 No No Current