MegaFresh

Manufacturer: American Amenities, Inc.
Effective date: 2015-01-16
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:41:24

Label at a glance#

ProductMegaFresh

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Fluoride (0.243%)

OTC - PURPOSE SECTION

Purpose: Anticavity

INDICATIONS & USAGE SECTION

Uses: Aids in the prevention of dental cavities

WARNINGS SECTION

For external use only. Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under six years of age

OTC - ASK DOCTOR SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Purified Water,Sorbitol, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Flavour, Carbomer Homopolymer Type C, Hydrated Silica, Saccharin Sodium,Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
891775	sodium fluoride 0.243 % Toothpaste	PSN	3
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	3
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	3
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	3
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	3
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54157-104-01	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-02	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-03	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-04	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-05	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-06	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-07	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-08	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-09	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-10	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-11	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-12	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-13	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-14	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-15	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-16	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-17	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-18	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-19	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee
54157-104-20	2020-01-31	C162847	48780-1	9d75b9d0-2cb6-f424-e053-dadaa90a57ce	803ebf8d-32bd-4060-b51b-88fca0a5ccee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54157-104-01	MegaFresh	17 g in 1 TUBE	GEL, DENTIFRICE	17	3
54157-104-02	MegaFresh	24 g in 1 TUBE	GEL, DENTIFRICE	24	3
54157-104-03	MegaFresh	35 g in 1 TUBE	GEL, DENTIFRICE	35	3
54157-104-04	MegaFresh	43 g in 1 TUBE	GEL, DENTIFRICE	43	3
54157-104-05	MegaFresh	50 g in 1 TUBE	GEL, DENTIFRICE	50	3
54157-104-06	MegaFresh	70 g in 1 TUBE	GEL, DENTIFRICE	70	3
54157-104-07	MegaFresh	78 g in 1 TUBE	GEL, DENTIFRICE	78	3
54157-104-08	MegaFresh	90 g in 1 TUBE	GEL, DENTIFRICE	90	3
54157-104-09	MegaFresh	100 g in 1 TUBE	GEL, DENTIFRICE	100	3
54157-104-10	MegaFresh	120 g in 1 TUBE	GEL, DENTIFRICE	120	3
54157-104-11	MegaFresh	130 g in 1 TUBE	GEL, DENTIFRICE	130	3
54157-104-12	MegaFresh	150 g in 1 TUBE	GEL, DENTIFRICE	150	3
54157-104-13	MegaFresh	181 g in 1 TUBE	GEL, DENTIFRICE	181	3
54157-104-14	MegaFresh	200 g in 1 TUBE	GEL, DENTIFRICE	200	3
54157-104-15	MegaFresh	4.25 g in 1 POUCH	GEL, DENTIFRICE	4.25	3
54157-104-16	MegaFresh	3 g in 1 POUCH	GEL, DENTIFRICE	3	3
54157-104-17	MegaFresh	5 g in 1 POUCH	GEL, DENTIFRICE	5	3
54157-104-18	MegaFresh	10 g in 1 POUCH	GEL, DENTIFRICE	10	3
54157-104-19	MegaFresh	71 g in 1 TUBE	GEL, DENTIFRICE	71	3
54157-104-20	MegaFresh	85 g in 1 TUBE	GEL, DENTIFRICE	85	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54157-104	MEGAFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERICAN AMENITIES, INC.]	3	Legacy NDC, 20 package rows	20150120_803ebf8d-32bd-4060-b51b-88fca0a5ccee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

MegaFresh
SODIUM FLUORIDE
FLUORIDE ION
WATER
SORBITOL
POLYETHYLENE GLYCOL 1500
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
CARBOMER HOMOPOLYMER TYPE C
HYDRATED SILICA
SACCHARIN SODIUM
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54157-104	54157-104-01, 54157-104-02, 54157-104-03, 54157-104-04, 54157-104-05, 54157-104-06, 54157-104-07, 54157-104-08, 54157-104-09, 54157-104-10, 54157-104-11, 54157-104-12, 54157-104-13, 54157-104-14, 54157-104-15, 54157-104-16, 54157-104-17, 54157-104-18, 54157-104-19, 54157-104-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	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 6 · 326 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, CHEWABLE / ORAL	24.75 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	SUPPOSITORY / RECTAL	0.3 mg/mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CREAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRALESIONAL		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		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
b64481d2-6ade-4eeb-b267-667e1085f1c0			803ebf8d-32bd-4060-b51b-88fca0a5ccee	2015-01-16	Warnings	Exact identifier spl id: b64481d2-6ade-4eeb-b267-667e1085f1c0 spl set id: 803ebf8d-32bd-4060-b51b-88fca0a5ccee

Reported adverse events (FAERS/openFDA)#

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