SPAI-SONS

Manufacturer: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date: 2012-08-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:15:33

Label at a glance#

ProductSPAI-SONS PROLAC-VIT

Active ingredientBIOTIN

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Biotin is a major component of the formulation acts to strengthen the hair follicle and prevents hair loss as well. It is nutrient for the hair root oxygenate the hair turn slowing the loss. Provides resilience and resistence to hair. Addition of biotin are other ingredient such as Asian Ginseng, Arginine, Zinc Gluconate, Niacinamide, Ornitine HCl, and Citrulline which help strengthen the hair follicle and produce a synergistic action on it.

OTC - PURPOSE SECTION

Prolac-vit is a well balanced formula that helps the function and nutrition of hair root, resulting in abundant hair and neutralizing alopecia caused by lack and certain components, mistreatment or toxic agents.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

This product must be keep out reach of children

INDICATIONS & USAGE SECTION

This product is for topical application directly on the hair follicle.

WARNINGS SECTION

Avoid contact with eyes, if they do wash with water. If swallowed contact a physician immediately

DOSAGE & ADMINISTRATION SECTION

Recommended use: thin or fragile, ill-treated hair, malnourished scalp or hair roots, Alopecia, hair loss due to cycle change.

Directions: must be applied directly to the scalp and then massage very gently until the product is absorbed

INACTIVE INGREDIENT SECTION

This is a liquid prepared with the technology needed to provide the hair follicle absorption of the active ingredients, plus inactive ingredients contribute to the regeneration of the hair fiber by providing a strengthening therefore. No adverse effects were seen with the use of this product as inactive ingredients do not cause skin hypersensivity.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF CARTON LABEL IMAGE OF CARTON LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-007-01	2019-11-13	C162847	48780-1	97449f38-b7c2-f6ea-e053-dbdaa90aa703	SPAI-SONS PROLAC-VIT
66854-007-02	2019-11-13	C162847	48780-1	97449f38-b7c2-f6ea-e053-dbdaa90aa703	SPAI-SONS PROLAC-VIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66854-007-01	SPAI-SONSPROLAC-VIT	70 mL in 1 BOTTLE	LIQUID	70		1
66854-007-02	SPAI-SONSPROLAC-VIT	10 mL in 1 BOTTLE	LIQUID	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-007	SPAI-SONS PROLAC-VIT (BIOTIN) LIQUID [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 2 package rows	20120808_4c294bea-5a61-4756-af3c-17ed30f2c0d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BIOTIN	ACTIVE INGREDIENT	6SO6U10H04	1
BIOTIN	ACTIVE MOIETY	6SO6U10H04	1
ALANINE	INACTIVE INGREDIENT	OF5P57N2ZX	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
AMNIOTIC FLUID (BOVINE)	INACTIVE INGREDIENT	P06X62O7E9	1
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	1
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	1
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	1
ASPARTIC ACID	INACTIVE INGREDIENT	30KYC7MIAI	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)	INACTIVE INGREDIENT	59TL3WG5CO	1
CITRULLINE	INACTIVE INGREDIENT	29VT07BGDA	1
CYSTINE	INACTIVE INGREDIENT	48TCX9A1VT	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
GLUCOSAMINE HYDROCHLORIDE	INACTIVE INGREDIENT	750W5330FY	1
GLUTAMIC ACID	INACTIVE INGREDIENT	3KX376GY7L	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	1
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	1
HYDROLYZED PLACENTAL PROTEIN (BOVINE)	INACTIVE INGREDIENT	KR5CS6RBH9	1
HYDROXYLYSINE	INACTIVE INGREDIENT	2GQB349IUB	1
HYDROXYPROLINE	INACTIVE INGREDIENT	RMB44WO89X	1
ISOLEUCINE	INACTIVE INGREDIENT	04Y7590D77	1
LEUCINE	INACTIVE INGREDIENT	GMW67QNF9C	1
LYSINE	INACTIVE INGREDIENT	K3Z4F929H6	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHIONINE	INACTIVE INGREDIENT	AE28F7PNPL	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
N-ACETYL-TYROSINE	INACTIVE INGREDIENT	DA8G610ZO5	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	1
ORNITHINE	INACTIVE INGREDIENT	E524N2IXA3	1
ORNITHINE HYDROCHLORIDE	INACTIVE INGREDIENT	HBK84K66XH	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	1
PEG-12 DIMETHICONE (300 CST)	INACTIVE INGREDIENT	ZEL54N6W95	1
PHENYLALANINE	INACTIVE INGREDIENT	47E5O17Y3R	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	1
POLYQUATERNIUM-11 (1000000 MW)	INACTIVE INGREDIENT	0B44BS5IJS	1
POLYQUATERNIUM-39 (35/35/30 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1500000 MW)	INACTIVE INGREDIENT	EOD3UE785A	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROLINE	INACTIVE INGREDIENT	9DLQ4CIU6V	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SERINE	INACTIVE INGREDIENT	452VLY9402	1
SULFUR	INACTIVE INGREDIENT	70FD1KFU70	1
THREONINE	INACTIVE INGREDIENT	2ZD004190S	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
TRYPTOPHAN	INACTIVE INGREDIENT	8DUH1N11BX	1
TYROSINE	INACTIVE INGREDIENT	42HK56048U	1
VALINE	INACTIVE INGREDIENT	HG18B9YRS7	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	1
ZINC GLUCONATE	INACTIVE INGREDIENT	U6WSN5SQ1Z	1

Products#

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

DailyMed product names page 1 of 2 · 52 matching rows.

SPAI-SONS PROLAC-VIT
BIOTIN
WATER
ALCOHOL
ASIAN GINSENG
ARGININE
N-ACETYL-TYROSINE
ARCTIUM LAPPA ROOT
ASPARTIC ACID
HYDROXYPROLINE
THREONINE
SERINE
GLUTAMIC ACID
PROLINE
GLYCINE
ALANINE
VALINE
METHIONINE
ISOLEUCINE
LEUCINE
TYROSINE
PHENYLALANINE
HYDROXYLYSINE
ORNITHINE
LYSINE
HISTIDINE
TRYPTOPHAN
CYSTINE
POLYQUATERNIUM-11 (1000000 MW)
PEG-12 DIMETHICONE (300 CST)
CALCIUM PANTOTHENATE
ZINC GLUCONATE
NIACINAMIDE
ORNITHINE HYDROCHLORIDE
CITRULLINE
GLUCOSAMINE HYDROCHLORIDE
PROPYLENE GLYCOL
AMNIOTIC FLUID (BOVINE)
HYDROLYZED PLACENTAL PROTEIN (BOVINE)
WHEAT GERM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66854-007	66854-007-01, 66854-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BIOTIN	6SO6U10H04	ACTIM
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
ASIAN GINSENG	CUQ3A77YXI	IACT
ARGININE	94ZLA3W45F	IACT
N-ACETYL-TYROSINE	DA8G610ZO5	IACT
ARCTIUM LAPPA ROOT	597E9BI3Z3	IACT
ASPARTIC ACID	30KYC7MIAI	IACT
HYDROXYPROLINE	RMB44WO89X	IACT
THREONINE	2ZD004190S	IACT
SERINE	452VLY9402	IACT
GLUTAMIC ACID	3KX376GY7L	IACT
PROLINE	9DLQ4CIU6V	IACT
GLYCINE	TE7660XO1C	IACT
ALANINE	OF5P57N2ZX	IACT
VALINE	HG18B9YRS7	IACT
METHIONINE	AE28F7PNPL	IACT
ISOLEUCINE	04Y7590D77	IACT
LEUCINE	GMW67QNF9C	IACT
TYROSINE	42HK56048U	IACT
PHENYLALANINE	47E5O17Y3R	IACT
HYDROXYLYSINE	2GQB349IUB	IACT
ORNITHINE	E524N2IXA3	IACT
LYSINE	K3Z4F929H6	IACT
HISTIDINE	4QD397987E	IACT
ARGININE	94ZLA3W45F	IACT
TRYPTOPHAN	8DUH1N11BX	IACT
CYSTINE	48TCX9A1VT	IACT
POLYQUATERNIUM-11 (1000000 MW)	0B44BS5IJS	IACT
PEG-12 DIMETHICONE (300 CST)	ZEL54N6W95	IACT
CALCIUM PANTOTHENATE	568ET80C3D	IACT
ZINC GLUCONATE	U6WSN5SQ1Z	IACT
NIACINAMIDE	25X51I8RD4	IACT
ORNITHINE HYDROCHLORIDE	HBK84K66XH	IACT
CITRULLINE	29VT07BGDA	IACT
GLUCOSAMINE HYDROCHLORIDE	750W5330FY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
AMNIOTIC FLUID (BOVINE)	P06X62O7E9	IACT
HYDROLYZED PLACENTAL PROTEIN (BOVINE)	KR5CS6RBH9	IACT
WHEAT GERM	YR3G369F5A	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 8 · 465 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHIONINE	METHIONINE	AE28F7PNPL	INJECTION, SUSPENSION / SUBCUTANEOUS	0.15 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
HISTIDINE	HISTIDINE	4QD397987E	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	0.16 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
LEUCINE	LEUCINE	GMW67QNF9C	INJECTION / INTRAVENOUS	1.1 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ASPARTIC ACID	ASPARTIC ACID	30KYC7MIAI	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
ISOLEUCINE	ISOLEUCINE	04Y7590D77	INJECTION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
HISTIDINE	HISTIDINE	4QD397987E	SUSPENSION / ORAL	5 mg/1ml		Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
THREONINE	THREONINE	2ZD004190S	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	160 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
METHIONINE	METHIONINE	AE28F7PNPL	INJECTION, SOLUTION / INTRAVENOUS	0.16 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	INJECTABLE, LIPOSOMAL / INTRAVENOUS	0.38 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
METHIONINE	METHIONINE	AE28F7PNPL	TABLET / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCINE	GLYCINE	TE7660XO1C	POWDER, FOR SOLUTION / ORAL	0.09 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHIONINE	METHIONINE	AE28F7PNPL	INJECTION / INTRAVENOUS		16 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	LOTION / TOPICAL		360 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HISTIDINE	HISTIDINE	4QD397987E	INJECTION / INTRAVENOUS		465 mg	Exact identifier — unii candidate 7 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
314f1ebc-353d-413e-beff-ddf3336e051a			4c294bea-5a61-4756-af3c-17ed30f2c0d8	2012-08-05	Warnings	Exact identifier spl id: 314f1ebc-353d-413e-beff-ddf3336e051a spl set id: 4c294bea-5a61-4756-af3c-17ed30f2c0d8

Reported adverse events (FAERS/openFDA)#

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