FDA.reportPublic FDA data

NDC 75053-0010-01 - Hypothaltem

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
75053-0010
Requested NDC
75053-0010-01
Package NDCs from labels
75053-0010-1, 75053-0010-01
Manufacturer
Nucleic Products, LLC | Apotheca Company
Effective date
2025-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hypothaltem - Nucleic Products, LLC | Apotheca CompanyNucleic Products, LLC | Apotheca Company2025-03-20HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75053-0010-1Hypothaltem118 mL in 1 BOTTLE, DROPPERLIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75053-0010HYPOTHALTEM (EUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIA) LIQUID [NUCLEIC PRODUCTS, LLC]4Current NDC, Legacy NDC, 1 package rows20250322_b95050f2-f40d-4e84-8752-4d7ad75390c9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 104 of 246 · 4,905 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Smart Care TEA and TIMBER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.f386dd34-325b-4c50-baf5-6b19c7953a752025-10-28WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsExact identifier
unii: 3K9958V90M
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsExact identifier
unii: 3K9958V90M
Smart Care CASHMERE CHAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.5fbdf5ce-77e1-498e-9543-312d10f3705e2025-10-28WarningsExact identifier
unii: 3K9958V90M
Smart Care ZEN and ZEST HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e3637e26-78f7-4913-ba02-390365b93a6d2025-10-28WarningsExact identifier
unii: 3K9958V90M
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421cfe98-7a20-c37c-e063-6294a90ad4b52025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce33e-4639-e881-e063-6394a90a57ef2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d994c-bf62-2f40-e063-6294a90a64882025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d2fd-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7bd9-c892-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
unii: 3K9958V90M
PreQuimmSILVER NITRATE,COLCHICUM AUTUMNALE BULB,CONIUM MACULATUM FLOWERING TOP,IPECAC,STRYCHNOS NUX VOMICA SEED,PULSATILLA PRATENSIS WHOLE,VERATRUM ALBUM ROOTZRG Detox, Inc.6db848aa-bf72-466e-8bc8-d02d073ed1202025-10-27WarningsExact identifier
unii: 269XH13919
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a26648-fd6e-9696-e053-2991aa0a5bf22025-10-27Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron7b4d5a40-7a53-11e6-a4bf-424c583030312025-10-27Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a28641-dd2f-b8a7-e053-2a91aa0a6d242025-10-27Exact identifier
unii: 639KR60Q1Q
SanicleanALCOHOLSimoniz Saniclean, LLC422533a2-9e14-8c7a-e063-6394a90a27e72025-10-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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