Home NDC 43846-0079 Bite, Bump and Rash Relief
Product NDC 43846-0079
11-digit product format 438460079
Labeler code 43846
Product ID 43846-0079_62504221-081d-488c-a478-95a59f401192
Type HUMAN OTC DRUG
Nonproprietary name Apis Mellifica, Astacus Fluviatilis, Belladonna, Calcarea Carbonica, Gelsemium Sempervirens, Mezereum, Rhus Tox
Dosage form GEL
Route TOPICAL
Labeler Peaceful Mountain, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-01-10
Marketing end 0000-00-00
Substance APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; ASTACUS ASTACUS; GELSEMIUM SEMPERVIRENS ROOT
Active strength 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43846-0079-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43846-0079-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43846-0079-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43846-0079-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43846-0079-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43846-0079-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43846-0079-1 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43846-0079 BITE, BUMP AND RASH RELIEF (APIS MELLIFICA, ASTACUS FLUVIATILIS, BELLADONNA, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, MEZEREUM, RHUS TOX) GEL [PEACEFUL MOUNTAIN, INC.] 3 Legacy NDC 20250523_e158a743-160f-446e-a0ea-a2ce566d866f.zip