Prostate

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:07

Label at a glance#

ProductProstate

Active ingredientThyroid, Unspecified, Barium Carbonate, Berberis Vulgaris Root Bark, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Cinchona Officinalis Bark, Conium Maculatum Flowering Top, Digitalis, Goldenseal, Iodine, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Chondrodendron Tomentosum Root, Pulsatilla Vulgaris, Saw Palmetto, Selenium, Delphinium Staphisagria Seed, Thuja Occidentalis Leafy Twig, Trifolium Pratense Flower, Echinacea, Unspecified, Arctium Lappa Root, Solidago Virgaurea Flowering Top, Ferric Picrate

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Prostate Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Thyroidinum 15x, Baryta carb. 10x , Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x , Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.

INACTIVE INGREDIENT SECTION

Gluten-free,non-GMO, beet-derived sucrose pellets.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
86fffa7b-d382-4771-a253-25cccb64b590	Product name	3	20251124
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
04cdd491-d111-4bc2-9549-75c575e1bd4b	Product name	1	20200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73	Product name	1	20200611
96a528e9-23e2-495f-81b9-ae87df2f7552	Product name	1	20191120
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
3df56c93-5837-4523-aac2-4b1ec48b9676	Product name	2	20160719
a883b7cc-d320-41d7-92ae-c873457ae641	Product name	1	20151116
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
bb23e78e-9e64-4037-a1c1-0e1d8762700e	Product name	1	20150325
ef06c001-572c-d95e-42f6-ee83da75673a	Product name	1	20140508
fd21f957-6863-d07b-5a35-250186878716	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4465-1	2020-01-31	C162847	48780-1	9d75b9d0-001f-f424-e053-dadaa90a57ce	Prostate
55714-4465-2	2020-01-31	C162847	48780-1	9d75b9d0-001f-f424-e053-dadaa90a57ce	Prostate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4465-1	Prostate	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4465-2	Prostate	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4465	PROSTATE (THYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC., TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGO) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131030_f2818813-e742-17f8-d77e-688e434c0f75.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arctium Lappa Root	ACTIVE INGREDIENT	597E9BI3Z3	1
Barium Carbonate	ACTIVE INGREDIENT	6P669D8HQ8	1
Berberis Vulgaris Root Bark	ACTIVE INGREDIENT	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Chondrodendron Tomentosum Root	ACTIVE INGREDIENT	395A3P448Z	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Delphinium Staphisagria Seed	ACTIVE INGREDIENT	00543AP1JV	1
Digitalis	ACTIVE INGREDIENT	F1T8QT9U8B	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Ferric Picrate	ACTIVE INGREDIENT	KZM8ZRY36A	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Iodine	ACTIVE INGREDIENT	9679TC07X4	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Oyster Shell Calcium Carbonate, Crude	ACTIVE INGREDIENT	2E32821G6I	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Saw Palmetto	ACTIVE INGREDIENT	J7WWH9M8QS	1
Selenium	ACTIVE INGREDIENT	H6241UJ22B	1
Solidago Virgaurea Flowering Top	ACTIVE INGREDIENT	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Thyroid, Unspecified	ACTIVE INGREDIENT	0B4FDL9I6P	1
Trifolium Pratense Flower	ACTIVE INGREDIENT	4JS0838828	1
Arctium Lappa Root	ACTIVE MOIETY	597E9BI3Z3	1
Barium Cation	ACTIVE MOIETY	V645272HLN	1
Berberis Vulgaris Root Bark	ACTIVE MOIETY	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Chondrodendron Tomentosum Root	ACTIVE MOIETY	395A3P448Z	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Delphinium Staphisagria Seed	ACTIVE MOIETY	00543AP1JV	1
Digitalis	ACTIVE MOIETY	F1T8QT9U8B	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Ferric Cation	ACTIVE MOIETY	91O4LML611	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Iodine	ACTIVE MOIETY	9679TC07X4	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Oyster Shell Calcium Carbonate, Crude	ACTIVE MOIETY	2E32821G6I	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Saw Palmetto	ACTIVE MOIETY	J7WWH9M8QS	1
Selenium	ACTIVE MOIETY	H6241UJ22B	1
Solidago Virgaurea Flowering Top	ACTIVE MOIETY	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	1
Thyroid, Unspecified	ACTIVE MOIETY	0B4FDL9I6P	1
Trifolium Pratense Flower	ACTIVE MOIETY	4JS0838828	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

Prostate
Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ., Trifolium pratense, Echinacea, Lappa, Solidago
Thyroid, Unspecified
Barium Carbonate
Barium Cation
Berberis Vulgaris Root Bark
Bryonia Alba Root
Oyster Shell Calcium Carbonate, Crude
Cinchona Officinalis Bark
Conium Maculatum Flowering Top
Digitalis
Goldenseal
Iodine
Lycopodium Clavatum Spore
Strychnos Nux-vomica Seed
Chondrodendron Tomentosum Root
Pulsatilla Vulgaris
Saw Palmetto
Selenium
Delphinium Staphisagria Seed
Thuja Occidentalis Leafy Twig
Trifolium Pratense Flower
Echinacea, Unspecified
Arctium Lappa Root
Solidago Virgaurea Flowering Top
Ferric Picrate
Ferric Cation
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4465	55714-4465-1, 55714-4465-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Thyroid, Unspecified	0B4FDL9I6P	ACTIB
Barium Carbonate	6P669D8HQ8	ACTIB
Berberis Vulgaris Root Bark	1TH8Q20J0U	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Oyster Shell Calcium Carbonate, Crude	2E32821G6I	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Digitalis	F1T8QT9U8B	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Iodine	9679TC07X4	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Chondrodendron Tomentosum Root	395A3P448Z	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Saw Palmetto	J7WWH9M8QS	ACTIB
Selenium	H6241UJ22B	ACTIB
Delphinium Staphisagria Seed	00543AP1JV	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Trifolium Pratense Flower	4JS0838828	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Arctium Lappa Root	597E9BI3Z3	ACTIB
Solidago Virgaurea Flowering Top	5405K23S50	ACTIB
Ferric Picrate	KZM8ZRY36A	ACTIM
Sucrose	C151H8M554	IACT

Source Document#

Source XML · Source PDF

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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 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
2b075b61-ae3e-8007-9080-3cc2566c6335			f2818813-e742-17f8-d77e-688e434c0f75	2011-06-01	Warnings	Exact identifier spl id: 2b075b61-ae3e-8007-9080-3cc2566c6335 spl set id: f2818813-e742-17f8-d77e-688e434c0f75

Reported adverse events (FAERS/openFDA)#

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