Lightening Night Cream

Manufacturer: LANGE SAS
Effective date: 2012-07-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:34:29

Label at a glance#

ProductLightening Night Cream

Active ingredientETHYL MACADAMIATE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

KEY ACTIVE INGREDIENTS
Seaweed, Monoi, Licorice and Pearl Protein Extracts

OTC - PURPOSE SECTION

LIGHTENING NIGHT CREAM LANGE
This lightening and moisturizing formula helps to:
Inhibit skin pigmentation,
Nourish and moisturize,
Soften and refine skin texture.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

This Whitening Seaweed inhibits melanin synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.

WARNINGS SECTION

WARNING!
Avoid contact with the eyes;
Avoid or afford protecting from UV
whilst using products containing AHA
because of the suggestion of susceptibility to
increased damage from UV.

DOSAGE & ADMINISTRATION SECTION

50 ml
1.7 FL. OZ

INACTIVE INGREDIENT SECTION

WATER
PEG-8
GLYCERIN
CAPRYLIC/CAPRIC TRIGLYCERIDE
ARACHIDYL ALCOHOL
METHYL GLUCETH-20
ETHYL MACADAMIATE
BEHENYL ALCOHOL
CAMELLIA KISSI SEED OIL
HEXYLDECANOL
HEXYLDECYL LAURATE
SODIUM POLYACRYLATE
PROPYLENE GLYCOL
CYCLOPENTASILOXANE
ARACHIDYL GLUCOSIDE
PHENOXYETHANOL
HYDROGENATED COCONUT OIL
SODIUM PCA
DISODIUM EDTA
PROPYLPARABEN
DIMETHICONOL
METHYLPARABEN
MAGNESIUM ASCORBYL PHOSPHATE
o-CYMEN-5-OL
TROMETHAMINE
ETHYLPARABEN
GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT
GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
BUTYLENE GLYCOL
TOCOPHEROL
GLYCERYL POLYACRYLATE
BAMBUSA VULGARIS EXTRACT
PANAX GINSENG ROOT EXTRACT
GARDENIA TAHITENSIS FLOWER
IRIS FLORENTINA ROOT EXTRACT
ASCOPHYLLUM NODOSUM EXTRACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LANGE
PARIS
LIGHTENING NIGHT CREAM
Moonlight with Seaweed extracts
50 ml
1.7 FL. OZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51830-020-05	2019-11-27	C162847	48780-1	9855d018-e60f-cd31-e053-dbdaa90ab51a	319afd46-a188-4941-982f-1b5e45158991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51830-020-05	Lightening Night Cream	50 mg in 1 BOX	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51830-020	LIGHTENING NIGHT CREAM (ETHYL MACADAMIATE) CREAM [LANGE SAS]	2	Legacy NDC, 1 package rows	20130213_319afd46-a188-4941-982f-1b5e45158991.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ETHYL MACADAMIATE	ACTIVE INGREDIENT	ANA2NCS6V1	2
ETHYL MACADAMIATE	ACTIVE MOIETY	ANA2NCS6V1	2
ACRYLIC ACID	INACTIVE INGREDIENT	J94PBK7X8S	2
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	2
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	2
ASCOPHYLLUM NODOSUM	INACTIVE INGREDIENT	168S4EO8YJ	2
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	2
BAMBUSA VULGARIS TOP	INACTIVE INGREDIENT	FIW80T6P6V	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	2
CAMELLIA KISSII SEED OIL	INACTIVE INGREDIENT	96HGN0T99A	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	2
DIMETHICONOL (100000 CST)	INACTIVE INGREDIENT	OSA9UP217S	2
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	2
GARDENIA TAITENSIS FLOWER	INACTIVE INGREDIENT	T0OCU8201Y	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	2
HEXYLDECANOL	INACTIVE INGREDIENT	151Z7P1317	2
HEXYLDECYL LAURATE	INACTIVE INGREDIENT	0V595C1P6M	2
HYDROGENATED COCONUT OIL	INACTIVE INGREDIENT	JY81OXM1OM	2
IRIS GERMANICA VAR. FLORENTINA ROOT	INACTIVE INGREDIENT	M30XO5X4XD	2
MAGNESIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	0R822556M5	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
METHYL GLUCETH-20	INACTIVE INGREDIENT	J3QD0LD11P	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
O-CYMEN-5-OL	INACTIVE INGREDIENT	H41B6Q1I9L	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM POLYACRYLATE (2500000 MW)	INACTIVE INGREDIENT	05I15JNI2J	2
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	2
TANGERINE	INACTIVE INGREDIENT	KH3E3096OO	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

Lightening Night Cream
Ethyl Macadamiate
WATER
POLYETHYLENE GLYCOL 400
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
ARACHIDYL ALCOHOL
METHYL GLUCETH-20
DOCOSANOL
CAMELLIA KISSII SEED OIL
HEXYLDECANOL
HEXYLDECYL LAURATE
SODIUM POLYACRYLATE (2500000 MW)
PROPYLENE GLYCOL
CYCLOMETHICONE 5
ARACHIDYL GLUCOSIDE
PHENOXYETHANOL
HYDROGENATED COCONUT OIL
SODIUM PYRROLIDONE CARBOXYLATE
EDETATE DISODIUM
PROPYLPARABEN
DIMETHICONOL (100000 CST)
METHYLPARABEN
MAGNESIUM ASCORBYL PHOSPHATE
O-CYMEN-5-OL
TROMETHAMINE
ETHYLPARABEN
GLYCYRRHIZA GLABRA
TANGERINE
ACRYLIC ACID
SUNFLOWER OIL
BUTYLENE GLYCOL
TOCOPHEROL
BAMBUSA VULGARIS TOP
ASIAN GINSENG
GARDENIA TAITENSIS FLOWER
IRIS GERMANICA VAR. FLORENTINA ROOT
ASCOPHYLLUM NODOSUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51830-020	51830-020-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ETHYL MACADAMIATE	ANA2NCS6V1	ACTIB
WATER	059QF0KO0R	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
GLYCERIN	PDC6A3C0OX	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
ARACHIDYL ALCOHOL	1QR1QRA9BU	IACT
METHYL GLUCETH-20	J3QD0LD11P	IACT
DOCOSANOL	9G1OE216XY	IACT
CAMELLIA KISSII SEED OIL	96HGN0T99A	IACT
HEXYLDECANOL	151Z7P1317	IACT
HEXYLDECYL LAURATE	0V595C1P6M	IACT
SODIUM POLYACRYLATE (2500000 MW)	05I15JNI2J	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
ARACHIDYL GLUCOSIDE	6JVW35JOOJ	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
HYDROGENATED COCONUT OIL	JY81OXM1OM	IACT
SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIMETHICONOL (100000 CST)	OSA9UP217S	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MAGNESIUM ASCORBYL PHOSPHATE	0R822556M5	IACT
O-CYMEN-5-OL	H41B6Q1I9L	IACT
TROMETHAMINE	023C2WHX2V	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
TANGERINE	KH3E3096OO	IACT
ACRYLIC ACID	J94PBK7X8S	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
TOCOPHEROL	R0ZB2556P8	IACT
BAMBUSA VULGARIS TOP	FIW80T6P6V	IACT
ASIAN GINSENG	CUQ3A77YXI	IACT
GARDENIA TAITENSIS FLOWER	T0OCU8201Y	IACT
IRIS GERMANICA VAR. FLORENTINA ROOT	M30XO5X4XD	IACT
ASCOPHYLLUM NODOSUM	168S4EO8YJ	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 9 · 487 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TROMETHAMINE	TROMETHAMINE	023C2WHX2V	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.24 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
TROMETHAMINE	TROMETHAMINE	023C2WHX2V	SOLUTION / INTRAVASCULAR	0.12 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROMETHAMINE	TROMETHAMINE	023C2WHX2V	CAPSULE / ORAL		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	GEL / VAGINAL		1250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
TROMETHAMINE	TROMETHAMINE	023C2WHX2V	SOLUTION / INTRATHECAL	0.12 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
TROMETHAMINE	TROMETHAMINE	023C2WHX2V	SOLUTION / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 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
618e21fc-0327-4292-a3a5-4ecfa0e31369			319afd46-a188-4941-982f-1b5e45158991	2012-07-18	Warnings	Exact identifier spl id: 618e21fc-0327-4292-a3a5-4ecfa0e31369 spl set id: 319afd46-a188-4941-982f-1b5e45158991

Reported adverse events (FAERS/openFDA)#

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