FDA.reportPublic FDA data

Smoke Control

Manufacturer
King Bio Inc.
Effective date
2011-10-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:03:19

Label at a glance#

ProductSmoke Control
Active ingredientARSENIC TRIOXIDE, DIEFFENBACHIA SEGUINE, PHENOL, DAPHNE ODORA BARK, SYZYGIUM JAMBOS SEED, POTASSIUM PHOSPHATE, DIBASIC, LOBELIA INFLATA, NICOTINE, STRYCHNOS NUX-VOMICA SEED, PLANTAGO MAJOR, SUCROSE, DELPHINIUM STAPHISAGRIA SEED, TOBACCO LEAF, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Indications and uses

Uses for temporary relief of symptoms: tobacco cravings (smoke and chew) headache shortness of breath cough nervousness tightness in chest irritability restlessness insomnia craving for stimulants nausea toxic effects of ingested substances anxiety poor concentration as per various homeopathic Materia Medicas Reference image smoke.jpg

Dosage and administration

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed. Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed. Reference image of smoke.jpg

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arsenicum album

Caladium seguinum

Carbolicum acidum

Daphne indica

Eugenia jambosa

Kali phosphoricum

Lobelia inflata

Nicotinum

Nux vomica

Plantago major

Saccharum officinale

Staphysagria

Tabacum

Thuja occidentalis

Reference image of smoke.jpg

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredients

Bio-Energetically Enhanced taste-free, pure water base

Reference image of smoke.jpg

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed.

Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed.

Reference image of smoke.jpg

Purpose

OTC - PURPOSE SECTION

HPUS active ingredients                        Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arsenicum album...........................................toxic effects of ingested substances

Caladium seguinum........................................headache, tobacco craving

Carbolicum acidum........................................craving for stimulants

Daphne indica................................................tobacco craving

Eugenia jambosa...........................................nausea, headache

Kali phosphoricum.........................................anxiety, restlessness

Lobelia inflata................................................shortness of breath

Nicotinum.....................................................poor concentration

Nux vomica..................................................irritability

Plantago major.............................................insomnia

Saccharum officinale...................................nutritional deficiency

Staphysagria...............................................acute cravings, nervousness

Tabacum.....................................................tightness in chest, fatigue

Thuja occidentalis........................................dry and painful cough

Reference image of smoke.jpg

Warnings

WARNINGS SECTION

If symptoms persist or worsen, seek advice of physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other information

Tamper resistant for your protection. Use only if safety seal is intact.

Reference image smoke.jpg

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Reference image smoke.jpg

Indications and Usage

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms:

  • tobacco cravings (smoke and chew)
  • headache
  • shortness of breath
  • cough
  • nervousness
  • tightness in chest
  • irritability
  • restlessness
  • insomnia
  • craving for stimulants
  • nausea
  • toxic effects of ingested substances
  • anxiety
  • poor concentration
as per various homeopathic Materia Medicas


Reference image smoke.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Image of carton label
Image of carton label

King Bio Inc.
3 Westside Drive
Asheville, NC 28806
www.kingbio.com

Reference image smoke.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5080-22020-01-31C16284748780-19d75b9d1-1abe-f424-e053-dadaa90a57ceSmoke Control

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5080-2Smoke Control59 mL in 1 BOTTLE, SPRAYLIQUID594
57955-5080-2Smoke Control1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5080SMOKE CONTROL (NATURAL MEDICINE) LIQUID [KING BIO INC.]4Legacy NDC, 2 package rows20111107_742a7702-ed5b-4ad0-a30e-9e13823f496f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO4
DAPHNE ODORA BARKACTIVE INGREDIENTJSJ34YQJ5D4
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV4
DIEFFENBACHIA SEGUINEACTIVE INGREDIENT01800C6E6B4
LOBELIA INFLATAACTIVE INGREDIENT9PP1T3TC5U4
NICOTINEACTIVE INGREDIENT6M3C89ZY6R4
PHENOLACTIVE INGREDIENT339NCG44TV4
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U4
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z4
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139194
SUCROSEACTIVE INGREDIENTC151H8M5544
SYZYGIUM JAMBOS SEEDACTIVE INGREDIENT97P0H458694
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93974
TOBACCO LEAFACTIVE INGREDIENT6YR2608RSU4
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HO4
DAPHNE ODORA BARKACTIVE MOIETYJSJ34YQJ5D4
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV4
DIEFFENBACHIA SEGUINEACTIVE MOIETY01800C6E6B4
LOBELIA INFLATAACTIVE MOIETY9PP1T3TC5U4
NICOTINEACTIVE MOIETY6M3C89ZY6R4
PHENOLACTIVE MOIETY339NCG44TV4
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U4
POTASSIUM CATIONACTIVE MOIETY295O53K1524
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139194
SUCROSEACTIVE MOIETYC151H8M5544
SYZYGIUM JAMBOS SEEDACTIVE MOIETY97P0H458694
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93974
TOBACCO LEAFACTIVE MOIETY6YR2608RSU4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-508057955-5080-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
DIEFFENBACHIA SEGUINE01800C6E6BACTIB
PHENOL339NCG44TVACTIB
DAPHNE ODORA BARKJSJ34YQJ5DACTIB
SYZYGIUM JAMBOS SEED97P0H45869ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
LOBELIA INFLATA9PP1T3TC5UACTIB
NICOTINE6M3C89ZY6RACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PLANTAGO MAJORW2469WNO6UACTIB
SUCROSEC151H8M554ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
TOBACCO LEAF6YR2608RSUACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT

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
0c0bd556-a792-477e-925d-5309fe5324b4742a7702-ed5b-4ad0-a30e-9e13823f496f2011-10-21WarningsExact identifier
spl id: 0c0bd556-a792-477e-925d-5309fe5324b4
spl set id: 742a7702-ed5b-4ad0-a30e-9e13823f496f

Reported adverse events (FAERS/openFDA)#

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