FDA.reportPublic FDA data

Thumb Thumb No Thumb

Manufacturer
Beautiful Day Organics, LLC
Effective date
2023-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:19:40

Label at a glance#

ProductThumb Thumb No Thumb
Active ingredientSACCHARUM OFFICINARUM WHOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Saccharum Off. (6X)..........................

OTC - PURPOSE SECTION

Purpose-Deterrent

INDICATIONS & USAGE SECTION

Use-May help deter thumb and finger sucking.

WARNINGS SECTION

Warnings:For external use only.
Allergy alert: Do not use if allergic to any of the ingredients

Do not use In or near the eyes.
Do not apply To broken or sore skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than intended use is swallowed, get
medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Children 2 years and older:  Wash thumb and fingers with warm water and soap.
Apply a liberal amount and rub evenly over
the entire thumb including the cuticle around
the fingernail.
Re-apply as needed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Bitter Green Gras, Citric Acid, Potassium
Sorbate, Water (purified), Xanthan Gum.

OTHER SAFETY INFORMATION

Other Info: Store at room temperature 68-77F (20-25C).Avoid direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thumb Thumb No Thumb             NDC 72715-001-03

NET WT 2.0 OZ (56g)

BDO_Thumb_Carton.jpgBDO_Thumb_Carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72715-001-022025-01-30C16284748780-12cef2736-76b0-d83d-e063-dadaa90ab31fDrug Facts
72715-001-032025-01-30C16284748780-12cef2736-76b0-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72715-001-02Thumb Thumb No Thumb56 g in 1 TUBEGEL564
72715-001-02Thumb Thumb No Thumb1 in 1 CARTONGEL14
72715-001-03Thumb Thumb No Thumb56 g in 1 TUBEGEL564
72715-001-03Thumb Thumb No Thumb1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72715-001THUMB THUMB NO THUMB (SACCHARUM OFF.) GEL [BEAUTIFUL DAY ORGANICS, LLC]4Legacy NDC, 4 package rows20230117_ce282545-1c8a-4ffa-89c7-68ac2a8dda53.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72715-00172715-001-02, 72715-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARUM OFFICINARUM WHOLE3Z20C92XNBACTIR
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

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
b5c9776c-f051-4f34-9be8-c8641057dc9cce282545-1c8a-4ffa-89c7-68ac2a8dda532023-01-09WarningsExact identifier
spl id: b5c9776c-f051-4f34-9be8-c8641057dc9c
spl set id: ce282545-1c8a-4ffa-89c7-68ac2a8dda53

Reported adverse events (FAERS/openFDA)#

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