Smokers Nicotine Relief

Manufacturer: TRP Company
Effective date: 2015-03-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:32:30

Label at a glance#

ProductSmokers Nicotine Relief

Active ingredientMILK THISTLE, ST. JOHN'S WORT, WOOD CREOSOTE, EPINEPHRINE, AVENA SATIVA FLOWERING TOP, LOBELIA INFLATA, STRYCHNOS NUX-VOMICA SEED, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, VALERIAN

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Adrenalinum HPUS 6x, 12x, 18x
Avena sativa HPUS 3x, 6x, 9x
Carduus marianus HPUS 3x, 6x
Hypericum HPUS 6x, 12x, 18x
Kreosotum HPUS 12x, 18x
Lobelia HPUS 6x, 12x
Nux vomica HPUS 6x, 12x, 18x
Quebracho HPUS 6x, 12x, 18x
Valeriana officinalis HPUS 6x, 12x, 18x

“HPUS” indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

INACTIVE INGREDIENT SECTION

Gum Base, Xylitol, Gum Arabic, Lactose, Natural flavor (Spearmint, Menthol), Artificial flavor, Maltitol, Isomalt, Stevia extract, Sorbitol, Shellac, Carnauba Wax

INDICATIONS & USAGE SECTION

According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: • cravings • withdrawal • irritability
• nicotine cleansing • cough/lung support after diagnosis by a physician.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.

• This product is intended to complement not replace standard smoking medical treatments. • Initial worsening of symptoms may occur.

OTC - PREGNANCY OR BREAST FEEDING SECTION

• If you are pregnant or breast-feeding, ask a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children under the age of 12.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if: • New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur.

OVERDOSAGE SECTION

• In case of overdose get medical help or contact a poison control center right away.

INSTRUCTIONS FOR USE SECTION

• Suitable for adults and children 12 years and above.
• For the first week before quitting, chew one piece of gum 6 times a day. • Do not smoke cigarettes after your quit date. • After your quit date for weeks 1 through 6, chew at least 9 pieces of gum per day or as often as needed instead of smoking a cigarette. • For weeks 7 through 12, chew at least 6 pieces of gum per day or as often as needed instead of smoking a cigarette. • After 12 weeks from your quit date, chew gum as needed. • Chew at least 10 minutes before or 10 minutes after eating. • Can use up to 20 pieces of gum per day. • Gum and Lozenges are interchangeable. • Homeopathic remedies may not be effective for everyone.

OTHER SAFETY INFORMATION

• There are no known contraindications. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
• Store in a cool dark location. • Smoker’s Nicotine ReliefTM Homeopathic Gum is a homeopathic dilution.

OTC - PURPOSE SECTION

Adrenalinum HPUS 6x, 12x, 18x................Stress, Fatigue
Avena sativa HPUS 3x, 6x, 9x...............Nicotine cleansing
Carduus marianus HPUS 3x, 6x....................Liver support
Hypericum HPUS 6x, 12x, 18x....Melancholy, Mood swings
Kreosotum HPUS 12x, 18x.....Mental Nicotine withdrawal
Lobelia HPUS 6x, 12x...........Physical Nicotine withdrawal
Nux vomica HPUS 6x, 12x, 18x...............Stress, Irritability
Quebracho HPUS 6x, 12x, 18x..........Cough / lung support
Valeriana officinalis HPUS 6x, 12x, 18x....Agitation, Anxiety

DOSAGE & ADMINISTRATION SECTION

For the first week before quitting, chew one piece of gum 6 times a day. Do not smoke cigarettes after your quit date. After your quit date for weeks 1 through 6, chew at least 9 pieces of gum per day or as often as needed instead of smoking a cigarette. For weeks 7 through 12, chew at least 6 pieces of gum per day or as often as needed instead of smoking a cigarette. After 12 weeks from your quit date, chew gum as needed. Chew at least 10 minutes before or 10 minutes after eating. Can use up to 20 pieces of gum per day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smokers Nicotine Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17312-035-16	2024-11-22	C162847	48780-1	9d75b9d0-b2db-f424-e053-dadaa90a57ce	Smokers Nicotine Relief
17312-035-16	2020-01-31	C162847	48780-1	9d75b9d0-b2db-f424-e053-dadaa90a57ce	Smokers Nicotine Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ASPIDOSPERMA QUEBRACHO-BLANCO BARK	ACTIVE INGREDIENT	52B1340190	1
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	1
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	1
LOBELIA INFLATA	ACTIVE INGREDIENT	9PP1T3TC5U	1
MILK THISTLE	ACTIVE INGREDIENT	U946SH95EE	1
ST. JOHN'S WORT	ACTIVE INGREDIENT	UFH8805FKA	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	1
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	1
WOOD CREOSOTE	ACTIVE INGREDIENT	3JYG22FD73	1
ASPIDOSPERMA QUEBRACHO-BLANCO BARK	ACTIVE MOIETY	52B1340190	1
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	1
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	1
LOBELIA INFLATA	ACTIVE MOIETY	9PP1T3TC5U	1
MILK THISTLE	ACTIVE MOIETY	U946SH95EE	1
ST. JOHN'S WORT	ACTIVE MOIETY	UFH8805FKA	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	1
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	1
WOOD CREOSOTE	ACTIVE MOIETY	3JYG22FD73	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1
CARBOXYMETHYLCELLULOSE	INACTIVE INGREDIENT	05JZI7B19X	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
ISOMALT	INACTIVE INGREDIENT	S870P55O2W	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	1
MENTHOL, UNSPECIFIED FORM	INACTIVE INGREDIENT	L7T10EIP3A	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SPEARMINT	INACTIVE INGREDIENT	J7I2T6IV1N	1
STEVIA REBAUDIUNA LEAF	INACTIVE INGREDIENT	6TC6NN0876	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Smokers Nicotine Relief
aspidosperma quebracho blanco, avena sativa, epinephrine, lobelia inflata, milk thistle, st johns wort, strychnos nux vomica seed, valerian, wood creosote
MILK THISTLE
ST. JOHN'S WORT
WOOD CREOSOTE
EPINEPHRINE
AVENA SATIVA FLOWERING TOP
LOBELIA INFLATA
STRYCHNOS NUX-VOMICA SEED
ASPIDOSPERMA QUEBRACHO-BLANCO BARK
VALERIAN
CARBOXYMETHYLCELLULOSE
XYLITOL
MALTITOL
ACACIA
LACTOSE
SPEARMINT
MENTHOL, UNSPECIFIED FORM
ISOMALT
STEVIA REBAUDIUNA LEAF
SORBITOL
SHELLAC
CARNAUBA WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17312-035	17312-035-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MILK THISTLE	U946SH95EE	ACTIB
ST. JOHN'S WORT	UFH8805FKA	ACTIB
WOOD CREOSOTE	3JYG22FD73	ACTIB
EPINEPHRINE	YKH834O4BH	ACTIB
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
LOBELIA INFLATA	9PP1T3TC5U	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
ASPIDOSPERMA QUEBRACHO-BLANCO BARK	52B1340190	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
XYLITOL	VCQ006KQ1E	IACT
MALTITOL	D65DG142WK	IACT
ACACIA	5C5403N26O	IACT
LACTOSE	J2B2A4N98G	IACT
SPEARMINT	J7I2T6IV1N	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
ISOMALT	S870P55O2W	IACT
STEVIA REBAUDIUNA LEAF	6TC6NN0876	IACT
SORBITOL	506T60A25R	IACT
SHELLAC	46N107B71O	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 183 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SUSPENSION / ORAL	39600 mg/120ml		Exact identifier — unii candidate 7 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
SPEARMINT	SPEARMINT	J7I2T6IV1N	TABLET, ORALLY DISINTEGRATING / ORAL	0.06 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, DELAYED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	FILM / SUBLINGUAL		24 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml		Exact identifier — unii candidate 8 equally ranked IID candidates
ISOMALT	ISOMALT	S870P55O2W	TABLET, CHEWABLE / ORAL		630 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	CAPSULE / ORAL	34.48 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SHELLAC	SHELLAC	46N107B71O	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE	CARBOXYMETHYLCELLULOSE	05JZI7B19X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORM	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9c5a15eb-7861-6750-e053-2a95a90a57ed			11e8fe93-8f88-473a-e054-00144ff88e88	2024-11-17	Warnings	Exact identifier spl set id: 11e8fe93-8f88-473a-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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