Rescue Calm

Product NDC
64578-0107
11-digit product format
645780107
Labeler code
64578
Product ID
64578-0107_4482dcc3-d827-459a-af0c-f9b56f1ed72e
Type
HUMAN OTC DRUG
Nonproprietary name
Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos
Dosage form
LIQUID
Route
ORAL
Labeler
Energetix Corp
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-08-25
Marketing end
0000-00-00
Substance
CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER
Active strength
30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct64578-0107IInactivated by FDA2026-10-05
excluded packagepackage64578-010764578-0107-1IInactivated by FDA2026-10-05

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64578-0107-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64578-0107-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64578-0107-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64578-0107-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64578-0107-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64578-0107-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64578-0107-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64578-0107-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64578-0107-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64578-0107-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64578-0107-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64578-0107-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64578-0107-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64578-0107-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64578-0107-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64578-0107-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64578-0107-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64578-0107-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64578-0107-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64578-0107-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64578-0107-19bebd1f3094a…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
64578-0107-12020-01-31C16284748780-19d75b9d0-7cff-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0107-1Rescue Calm59.1 mL in 1 BOTTLE, DROPPERLIQUID59.14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLEMATIS VITALBA FLOWERACTIVE INGREDIENT7SCP4N87CIRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE INGREDIENT51BRR32WPPRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
IMPATIENS GLANDULIFERA FLOWERACTIVE INGREDIENTAJU5O1A5ZVRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ORNITHOGALUM UMBELLATUM FLOWERING TOPACTIVE INGREDIENTCZD6M4PY4BRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
PRUNUS CERASIFERA FLOWERACTIVE INGREDIENT0KD7R09EASRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
CLEMATIS VITALBA FLOWERACTIVE MOIETY7SCP4N87CIRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
HELIANTHEMUM NUMMULARIUM FLOWERACTIVE MOIETY51BRR32WPPRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
IMPATIENS GLANDULIFERA FLOWERACTIVE MOIETYAJU5O1A5ZVRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ORNITHOGALUM UMBELLATUM FLOWERING TOPACTIVE MOIETYCZD6M4PY4BRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
PRUNUS CERASIFERA FLOWERACTIVE MOIETY0KD7R09EASRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1
waterINACTIVE INGREDIENT059QF0KO0RRESCUE CALM (HOMEOPATHIC LIQUID) LIQUID [ENERGETIX CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64578-0107RESCUE CALM (CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS) LIQUID [ENERGETIX CORP]4Legacy NDC, 1 package rows20181128_ed7bf66b-7480-4a43-9d97-e8c63207e4ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64578-0107-16457801070159.1 mL in 1 BOTTLE, DROPPER59.1 mlHistorical