FDA.reportPublic FDA data

OSTEOBIOS

Manufacturer
Guna spa
Effective date
2022-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:30

Label at a glance#

ProductOSTEOBIOS
Active ingredientCALCITONIN HUMAN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CALCIUM CARBONATE, CALCIUM FLUORIDE, CALCIUM PHOSPHATE, SUS SCROFA BONE, SUS SCROFA PARATHYROID GLAND
Label structure10 sections

Indications and uses

Temporary relief of symptoms related weak bones such as: Frequent and slow-healing fractures Sharp and dull bone pain

Dosage and administration

Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

BONE 10X 30X 200X BONE FRACTURES

CALCAREA FLUORICA 12X 30X 200X BONE FRACTURES

CALCAREA CARBONICA 12X 30X 200X BONE FRACTURES

CALCAREA PHOSPHORICA 12X 30X 200X BONE FRACTURES

CALCITONIN 6X BONE FRACTURES

PARATHYROID GLAND 10X 30X 200X IMPROVES BONE REPAIR


USES

OTC - PURPOSE SECTION

Temporary relief of symptoms related weak bones such as:

  • Frequent and slow-healing fractures
  • Sharp and dull bone pain

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

Children under 6 years 5 drops in a glass of water, 2 times per day

QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com, tel. (484) 223-3500

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethyl alcohol 30%.

INDICATIONS & USAGE SECTION

Take 15 minutes before meals

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USOST-REV05-03-04-185USOST-REV05-03-04-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17089-259-182020-03-13C16284748780-19d75b9cf-f0a1-f424-e053-dadaa90a57ceOSTEOBIOS
17089-259-182020-01-31C16284748780-19d75b9cf-f0a1-f424-e053-dadaa90a57ceOSTEOBIOS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-259-18OSTEOBIOS30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS305
17089-259-18OSTEOBIOS1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-259OSTEOBIOS (CALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - TRYPTOPHAN - VALINE -) SOLUTION/ DROPS [GUNA SPA]5Current NDC, Legacy NDC, 2 package rows20221115_1b8c8c83-1a46-4c0a-b883-e7dce781c5d1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCITONIN HUMANACTIVE INGREDIENTI0IO9290191
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
CALCIUM PHOSPHATEACTIVE INGREDIENT97Z1WI3NDX1
ISOLEUCINEACTIVE INGREDIENT04Y7590D771
LEUCINEACTIVE INGREDIENTGMW67QNF9C1
LYSINEACTIVE INGREDIENTK3Z4F929H61
METHIONINEACTIVE INGREDIENTAE28F7PNPL1
PHENYLALANINEACTIVE INGREDIENT47E5O17Y3R1
SUS SCROFA BONEACTIVE INGREDIENT597RLJ09RG1
SUS SCROFA PARATHYROID GLANDACTIVE INGREDIENT2KBE35NE8S1
THREONINEACTIVE INGREDIENT2ZD004190S1
TRYPTOPHANACTIVE INGREDIENT8DUH1N11BX1
VALINEACTIVE INGREDIENTHG18B9YRS71
CALCITONIN HUMANACTIVE MOIETYI0IO9290191
CALCIUM FLUORIDEACTIVE MOIETYO3B55K4YKI1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
ISOLEUCINEACTIVE MOIETY04Y7590D771
LEUCINEACTIVE MOIETYGMW67QNF9C1
LYSINEACTIVE MOIETYK3Z4F929H61
METHIONINEACTIVE MOIETYAE28F7PNPL1
PHENYLALANINEACTIVE MOIETY47E5O17Y3R1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR1
SUS SCROFA BONEACTIVE MOIETY597RLJ09RG1
SUS SCROFA PARATHYROID GLANDACTIVE MOIETY2KBE35NE8S1
THREONINEACTIVE MOIETY2ZD004190S1
TRYPTOPHANACTIVE MOIETY8DUH1N11BX1
VALINEACTIVE MOIETYHG18B9YRS71
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-25917089-259-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CALCITONIN HUMANI0IO929019ACTIB
ISOLEUCINE04Y7590D77ACTIB
LEUCINEGMW67QNF9CACTIB
LYSINEK3Z4F929H6ACTIB
METHIONINEAE28F7PNPLACTIB
PHENYLALANINE47E5O17Y3RACTIB
THREONINE2ZD004190SACTIB
TRYPTOPHAN8DUH1N11BXACTIB
VALINEHG18B9YRS7ACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALCIUM PHOSPHATE97Z1WI3NDXACTIB
SUS SCROFA BONE597RLJ09RGACTIB
SUS SCROFA PARATHYROID GLAND2KBE35NE8SACTIB

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 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSTEOBIOSCALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - TRYPTOPHAN - VALINE -Guna spa1b8c8c83-1a46-4c0a-b883-e7dce781c5d12022-11-14WarningsExact identifier
ndc (package): 17089-259-18
ndc (product): 17089-259
ndc11 (package): 17089025918
spl id: ed712a71-07a8-02bc-e053-2995a90a8c42
spl set id: 1b8c8c83-1a46-4c0a-b883-e7dce781c5d1

Reported adverse events (FAERS/openFDA)#

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