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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43846-0079DDiscontinued by firm2026-10-05
excluded packagepackage43846-007943846-0079-1DDiscontinued by firm2026-10-05

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43846-0079-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43846-0079-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43846-0079-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43846-0079-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43846-0079-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43846-0079-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43846-0079-18dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0079-12024-06-13C16284748780-1ba0f9c33-2464-a910-e053-dadaa90a0b85DRUG FACTS:
43846-0079-12021-01-29C16284748780-1ba0f9c33-2464-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0079BITE, BUMP AND RASH RELIEF (APIS MELLIFICA, ASTACUS FLUVIATILIS, BELLADONNA, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, MEZEREUM, RHUS TOX) GEL [PEACEFUL MOUNTAIN, INC.]3Legacy NDC20250523_e158a743-160f-446e-a0ea-a2ce566d866f.zip