FDA.reportPublic FDA data

Viiva

Manufacturer
Viiva LLC
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:38

Label at a glance#

ProductViiva
Active ingredientSOMATROPIN
Label structure6 sections

Dosage and administration

Apply two full pumps in the evening. Gently massage all over face and neck. You may also apply the serum to your hands and forearms. Store the product at room temperature and away from sunlight.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Somatropin 12X

Purpose

OTC - PURPOSE SECTION

Anti-Aging', Improve Sleep', Immune Health', Bone & Joint Health', Skin Health', Increase Muscle', Reduce Fat'

'These statement have not been evaluted by FDA

Directions

INDICATIONS & USAGE SECTION

Apply two full pumps in the evening. Gently massage all over face and neck. You may also apply the serum to your hands and forearms. Store the product at room temperature and away from sunlight.

Warning

WARNINGS SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Panthenol, Glycerin, Arginine/Lysine Polypeptide, Dipropylene Glycol, Pentylene Glycol, Nicotinamide Mononucleotide, Melatonin, Arginine, Lysine, Ornithine, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Lecithin, Sodium Hyaluronate, Sodium Acetylated
Hyaluronate, Pterocarpus Marsupium Bark Extract, Madecassoside, Hydroxyacetophenone, 1,2-Hexanediol, Butylene Glycol, Polysorbate 20,
Xanthan Gum, Disodium EDTA

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78362-802-012023-01-30C16284748780-1f386c64a-158e-0266-e053-dadaa90a7c1ab28cf2f5-1da2-4763-ab3b-222dddfd29dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78362-802-01Viiva31 mL in 1 BOTTLE, PUMPGEL311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78362-802VIIVA (SOMATROPIN 12X) GEL [VIIVA LLC]1Legacy NDC, 1 package rows20201126_b28cf2f5-1da2-4763-ab3b-222dddfd29dd.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78362-80278362-802-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOMATROPINNQX9KB6PCLACTIB
WATER059QF0KO0RIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
ARGININE94ZLA3W45FIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PENTYLENE GLYCOL50C1307PZGIACT
NIACINAMIDE25X51I8RD4IACT
MELATONINJL5DK93RCLIACT
LYSINEK3Z4F929H6IACT
ORNITHINEE524N2IXA3IACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
PTEROCARPUS MARSUPIUM BARKB6227M1TS0IACT
MADECASSOSIDECQ2F5O6YIYIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POLYSORBATE 207T1F30V5YHIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
781489a9-e431-4ce3-919a-f05783f44d0eb28cf2f5-1da2-4763-ab3b-222dddfd29dd2020-11-20WarningsExact identifier
spl id: 781489a9-e431-4ce3-919a-f05783f44d0e
spl set id: b28cf2f5-1da2-4763-ab3b-222dddfd29dd

Reported adverse events (FAERS/openFDA)#

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