| Drug NDC: | 66096-712 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | |
| Proprietary Name: | Joette Calabrese Survivalist Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary Name: | Abrot Acon Agn Ail Ambr Ambro Am-c Ant-c Apis Arn Ars Aur-a Aur Bapt Bar-c Bell Bb Both Bov Brom Cadm-s Calad Calc Camph Carb-ac Card-m Cean Chel Chinin-a Cina Chin Cic Cob Colch Con Crot-h Crot-t Cupr Dulc Elaps Eup-per Fl-ac Galph Graph Gunp Ham Hekla Hell Hep Hydr-ac Hyos Hyper Kali-br Kali-c Kali-i Lath Laur Led Lob Merc-cy Merc Mez Mosch Mur-ac Naja Nat-c Nit-ac Nux-m Pyrog Ph-ac Pic-ac Plb Rhus-t Ruta Samb Sang Sarr Sep Stram Sul-ac Tab Terent Ter Teucr Verat Verat-v Vip |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Ohm Pharma Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Pellet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | ACONITUM NAPELLUS - 1 [hp_M]/1 AETHUSA CYNAPIUM - 200 [hp_C]/1 AILANTHUS ALTISSIMA FLOWERING TWIG - 30 [hp_C]/1 AMBERGRIS - 30 [hp_C]/1 AMBROSIA ARTEMISIIFOLIA POLLEN - 30 [hp_C]/1 AMMONIUM CARBONATE - 30 [hp_C]/1 ANTIMONY TRISULFIDE - 6 [hp_C]/1 APIS MELLIFERA - 1 [hp_M]/1 ARNICA MONTANA - 3 [hp_C]/1 ARSENIC TRIOXIDE - 3 [hp_C]/1 Load more... ARTEMISIA ABROTANUM FLOWERING TOP - 6 [hp_C]/1 ARTEMISIA CINA PRE-FLOWERING TOP - 3 [hp_X]/1 ATROPA BELLADONNA - 3 [hp_C]/1 BAPTISIA TINCTORIA ROOT - 200 [hp_C]/1 BARIUM CARBONATE - 30 [hp_C]/1 BORRELIA BURGDORFERI - 200 [hp_C]/1 BOTHROPS ATROX VENOM - 30 [hp_C]/1 BROMINE - 30 [hp_C]/1 CADMIUM SULFATE - 30 [hp_C]/1 CALCIUM SULFIDE - 6 [hp_C]/1 CAMPHOR (NATURAL) - 200 [hp_C]/1 CEANOTHUS AMERICANUS LEAF - 30 [hp_C]/1 CHASTE TREE - 200 [hp_C]/1 CHELIDONIUM MAJUS - 6 [hp_C]/1 CICUTA VIROSA ROOT - 30 [hp_C]/1 CINCHONA OFFICINALIS BARK - 3 [hp_C]/1 CLAVICEPS PURPUREA SCLEROTIUM - 6 [hp_C]/1 COBALT - 30 [hp_C]/1 COLCHICUM AUTUMNALE BULB - 30 [hp_C]/1 CONIUM MACULATUM FLOWERING TOP - 3 [hp_C]/1 COPPER - 6 [hp_C]/1 CROTALUS HORRIDUS HORRIDUS VENOM - 6 [hp_C]/1 CROTON TIGLIUM SEED - 30 [hp_C]/1 DAPHNE MEZEREUM BARK - 200 [hp_C]/1 DATURA STRAMONIUM - 30 [hp_C]/1 DIEFFENBACHIA SEGUINE - 30 [hp_C]/1 EUPATORIUM PERFOLIATUM FLOWERING TOP - 200 [hp_C]/1 GALPHIMIA GLAUCA FLOWERING TOP - 30 [hp_C]/1 GOLD - 200 [hp_C]/1 GRAPHITE - 200 [hp_C]/1 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 200 [hp_C]/1 HEKLA LAVA - 30 [hp_C]/1 HELLEBORUS NIGER ROOT - 30 [hp_C]/1 HYDROCHLORIC ACID - 30 [hp_C]/1 HYDROFLUORIC ACID - 30 [hp_C]/1 HYDROGEN CYANIDE - 30 [hp_C]/1 HYOSCYAMUS NIGER - 6 [hp_C]/1 HYPERICUM PERFORATUM - 1 [hp_M]/1 LATHYRUS SATIVAS SEED - 30 [hp_C]/1 LEAD - 30 [hp_C]/1 LEDUM PALUSTRE TWIG - 1 [hp_M]/1 LOBELIA INFLATA - 30 [hp_C]/1 LYCOPERDON UTRIFORME FRUITING BODY - 30 [hp_C]/1 LYCOSA TARANTULA - 30 [hp_C]/1 MERCURIC CYANIDE - 200 [hp_C]/1 MERCURIUS SOLUBILIS - 6 [hp_C]/1 MICRURUS CORALLINUS VENOM - 30 [hp_C]/1 MILK THISTLE - 30 [hp_C]/1 MOSCHUS MOSCHIFERUS WHOLE - 30 [hp_C]/1 NAJA NAJA VENOM - 30 [hp_C]/1 NITRIC ACID - 30 [hp_C]/1 NUTMEG - 30 [hp_C]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE - 1 [hp_M]/1 PHENOL - 6 [hp_C]/1 PHOSPHORIC ACID - 6 [hp_C]/1 PICRIC ACID - 200 [hp_C]/1 POTASSIUM BROMIDE - 30 [hp_C]/1 POTASSIUM CARBONATE - 200 [hp_C]/1 POTASSIUM IODIDE - 6 [hp_C]/1 PRUNUS LAUROCERASUS LEAF - 30 [hp_C]/1 QUININE SULFATE - 3 [hp_X]/1 RANCID BEEF - 200 [hp_C]/1 RUTA GRAVEOLENS FLOWERING TOP - 6 [hp_C]/1 SAMBUCUS NIGRA FLOWERING TOP - 30 [hp_C]/1 SANGUINARIA CANADENSIS ROOT - 200 [hp_C]/1 SARRACENIA PURPUREA - 30 [hp_C]/1 SEPIA OFFICINALIS JUICE - 6 [hp_C]/1 SODIUM CARBONATE - 30 [hp_C]/1 SOLANUM DULCAMARA TOP - 30 [hp_C]/1 SULFURIC ACID - 30 [hp_C]/1 TEUCRIUM MARUM - 200 [hp_C]/1 TOBACCO LEAF - 30 [hp_C]/1 TOXICODENDRON PUBESCENS LEAF - 1 [hp_M]/1 TURPENTINE OIL - 6 [hp_C]/1 VERATRUM ALBUM ROOT - 200 [hp_C]/1 VERATRUM VIRIDE ROOT - 30 [hp_C]/1 VIPERA BERUS VENOM - 30 [hp_C]/1 |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Start Date: | 26 Oct, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | OHM PHARMA INC. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000185006 N0000175629 N0000184306 N0000185001 M0017130 M0000728 N0000185021 M0002274 N0000185508 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185371 N0000185375 M0016962 M0006342 M0008672 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | U0NQ8555JD M6936L953C 8P29O5P7XU XTC0D02P6C K20Y81ACO3 NJ5VT0FKLJ F79059A38U 7S82P3R43Z O80TY208ZW S7V92P67HO Load more... QG07G580U0 28M1820ACT WQZ3G9PF0H 5EF0HWI5WU 6P669D8HQ8 0J8NV9V5Q8 K0Q6REZ9JC SBV4XY874G 947UNF3Z6O 1MBW07J51Q N20HL7Q941 25B1Y14T8N 433OSF3U8A 7E889U5RNN YEA9P21S8N S003A158SB 01G9XEA93N 3G0H8C9362 993QHL78E6 Q28R5GF371 789U1901C5 YHA2XLJ956 0HK2GZK66E X2N6E405GV G6W4F0V8Z3 01800C6E6B 1W0775VX6E 93PH5Q8M7E 79Y1949PYO 4QQN74LH4O T7S323PKJS C21158IIRK 608DGJ6815 QTT17582CB RGL5YE86CZ 2WTB3V159F 4WRK2153H3 XK4IUX8MNB 8VP54WOT4I 2P299V784P 877L01IZ0P 9PP1T3TC5U K2A74U428F 86M454L2TT RWG7BD1032 324Y4038G2 V0S6H36980 U946SH95EE W5Y0EFG88O ZZ4AG7L7VM 411VRN1TV4 AEE24M3MQ9 2E32821G6I 339NCG44TV E4GA8884NN A49OS0F91S OSD78555ZM BQN1B9B9HA 1C4QK22F9J F26P2D4757 KF7Z0E0Q2B 29SUH5R3HU N94C2U587S CT03BSA18U N9288CD508 FOP08H143P QDL83WN8C2 45P3261C7T KPS1B1162N O40UQP6WCF 10464S0TAA 6YR2608RSU 6IO182RP7A C5H0QJ6V7F QNS6W5US1Z 197B3Q7T5Q 0ORO6NCA4M |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Standardized Pollen Allergenic Extract [EPC] Standardized Insect Venom Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] Copper-containing Intrauterine Device [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Pollen [CS] Allergens [CS] Bee Venoms [CS] Copper [CS] Plant Proteins [CS] Dietary Proteins [CS] Food Additives [CS] Seed Storage Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Antimalarial [EPC] Bee Venoms [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Inhibit Ovum Fertilization [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Pollen [CS] Seed Storage Proteins [CS] Standardized Chemical Allergen [EPC] Standardized Insect Venom Allergenic Extract [EPC] Standardized Pollen Allergenic Extract [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 66096-712-27 | 100 PELLET in 1 KIT (66096-712-27) | 26 Oct, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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