Hot Flash Rescue

Product NDC
57520-0455
11-digit product format
575200455
Labeler code
57520
Product ID
57520-0455_5419af8a-1318-4947-a69b-029b1e7c9345
Type
HUMAN OTC DRUG
Nonproprietary name
Capsicum annuum, Pulsatilla, Sanguinaria canadensis,
Dosage form
LOTION
Route
TOPICAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-06-21
Marketing end
2023-10-03
Substance
CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT
Active strength
3 [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
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 productproduct57520-0455DDiscontinued by firm2026-10-16
excluded packagepackage57520-045557520-0455-1DDiscontinued 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 · 36 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued 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 packagepackage57520-0455-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57520-0455-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0455-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0455-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0455-1IInactivated 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 packagepackage57520-0455-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0455-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
57520-0455-12022-04-28C16284748780-19d75b9cf-d92b-f424-e053-dadaa90a57ceHot Flash Rescue
57520-0455-12020-01-31C16284748780-19d75b9cf-d92b-f424-e053-dadaa90a57ceHot Flash Rescue

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUMACTIVE INGREDIENT00UK7646FGHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD508HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
CAPSICUMACTIVE MOIETY00UK7646FGHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD508HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
BLACK COHOSHINACTIVE INGREDIENTK73E24S6X9HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))INACTIVE INGREDIENT59TL3WG5COHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
CHASTE TREEINACTIVE INGREDIENT433OSF3U8AHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
DIOSCOREA VILLOSA ROOTINACTIVE INGREDIENTIWY3IWX2G8HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
MACADAMIA OILINACTIVE INGREDIENT515610SU8CHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
OREGANO FLOWERING TOPINACTIVE INGREDIENT7K91ZBK8GJHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
ROSA CANINA FRUIT OILINACTIVE INGREDIENTCR7307M3QZHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
SAGEINACTIVE INGREDIENT065C5D077JHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKAHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RHOT FLASH RESCUE (CAPSICUM ANNUUM, PULSATILLA, SANGUINARIA CANADENSIS,) LOTION [APOTHECA COMPANY]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57520-0455-157520045501100 g in 1 BOTTLE, PUMP (57520-0455-1) 100 g2011-06-212023-10-03NoNoCurrent