Hot Flash Rescue

Product NDC
43846-0033
11-digit product format
438460033
Labeler code
43846
Product ID
43846-0033_1a71c9ed-7a20-41e1-83f3-9fe1e7b104a1
Type
HUMAN OTC DRUG
Nonproprietary name
Capsicum Annuum, Pulsatilla, Sanguinaria Candensis
Dosage form
LOTION
Route
TOPICAL
Labeler
Peaceful Mountain, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-01-02
Marketing end
2022-09-03
Substance
CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT
Active strength
3 [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct43846-0033DDiscontinued by firm2026-10-16
excluded packagepackage43846-003343846-0033-1DDiscontinued by firm2026-10-16

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43846-0033-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43846-0033-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43846-0033-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43846-0033-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43846-0033-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43846-0033-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43846-0033-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43846-0033-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43846-0033-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43846-0033-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43846-0033-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43846-0033-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43846-0033-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43846-0033-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
43846-0033-12021-12-13C16284748780-19d75b9d0-be0f-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0033-12020-01-31C16284748780-19d75b9d0-be0f-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUMACTIVE INGREDIENT00UK7646FGHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD508HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
CAPSICUMACTIVE MOIETY00UK7646FGHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD508HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
BLACK COHOSHINACTIVE INGREDIENTK73E24S6X9HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
CHASTE TREEINACTIVE INGREDIENT433OSF3U8AHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
DIOSCOREA VILLOSA ROOTINACTIVE INGREDIENTIWY3IWX2G8HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNBHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
MACADAMIA OILINACTIVE INGREDIENT515610SU8CHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
OREGANOINACTIVE INGREDIENT0E5AT8T16UHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
SAGEINACTIVE INGREDIENT065C5D077JHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANDENSIS) LOTION [PEACEFUL MOUNTAIN, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43846-0033-143846003301100 g in 1 BOTTLE, PUMP (43846-0033-1) 100 g2014-01-022022-09-03NoNoCurrent