Beyond Nicotine

Manufacturer
JMSP USA LLC | W Last CC
Effective date
2017-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:50

Label at a glance#

ProductBeyond Nicotine
Active ingredientPOTASSIUM SULFATE, NICOTINE, PLANTAGO MAJOR, TOBACCO LEAF
Label structure8 sections

Indications and uses

A pump spray under the tongue up to 10 when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

Dosage and administration

One pump spray under the tongue up to 10 times a day or when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

Label contents#

Full prescribing information#

Active Ingrdietns 

OTC - ACTIVE INGREDIENT SECTION

Kali Sulph 6x

Nicotinum 9cH

Plantago 9cH

Tabacum 9cH

Purpose of ingredients:

OTC - PURPOSE SECTION

Traditionally used to alleviate craving for and discomfort from smoking or vaping.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

Warnings:

WARNINGS SECTION

  • Not intended for pregnant or lactating women
  • Not to be taken by those with existing medical conditions, please consult your physician prior to use.

Indications and Usage:

INDICATIONS & USAGE SECTION

A pump spray under the tongue up to 10 when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified Water and Ethyl Alcohol

Directions 

DOSAGE & ADMINISTRATION SECTION

One pump spray under the tongue up to 10 times a day or when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nicotin frontnicotin front

ncotine backncotine back

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58214-789-012020-01-31C16284748780-19d75b9d0-6004-f424-e053-dadaa90a57ceBeyond Nicotine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58214-789-01Beyond Nicotine30 mL in 1 PACKAGESPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58214-789BEYOND NICOTINE (KALI SULPH, NICOTINUM , PLANTAGO AND TABACUM) SPRAY [JMSP USA LLC]1Legacy NDC, 1 package rows20170613_1045452b-a62b-438b-81d5-f9c73bf3f64d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58214-78958214-789-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f9552597-c0a4-4c18-aed0-a26523759b8e1045452b-a62b-438b-81d5-f9c73bf3f64d2017-06-12WarningsExact identifier
spl id: f9552597-c0a4-4c18-aed0-a26523759b8e
spl set id: 1045452b-a62b-438b-81d5-f9c73bf3f64d

Reported adverse events (FAERS/openFDA)#

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