FDA.reportPublic FDA data

Baby Teething Plus Tooth Support

Manufacturer
Similasan Corporation
Effective date
2014-09-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:55

Label at a glance#

ProductBaby Teething Plus Tooth Support
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, PODOPHYLLUM
Label structure21 sections

Indications and uses

According to the homeopathic principles, the active ingredients in this product: temporarily relieve restlessness & irritability due to painful gums support dental development

Dosage and administration

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcarea carbonica 12X

Purpose

OTC - PURPOSE SECTION

pain, difficult dentition

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcarea fluorica 12X

Purpose

OTC - PURPOSE SECTION

supports dental development

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcarea phosphorica 12X

Purpose

OTC - PURPOSE SECTION

supports dental development, pain, slow dentition

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 8X

Purpose

OTC - PURPOSE SECTION

swelling, irritability, restlessness, sleeplessness, red cheek/face

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ferrum phosphoricum 12X      

Purpose

OTC - PURPOSE SECTION

fussiness or restlessness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Podophyllum peltatum 12X

Purpose

OTC - PURPOSE SECTION

drooling, chewing on things, irritability

Uses:

INDICATIONS & USAGE SECTION

According to the homeopathic principles, the active ingredients in this product:

  • temporarily relieve restlessness & irritability due to painful gums
  • support dental development

Warnings:

WARNINGS SECTION

  • Initial exacerbation of symptoms may occur.
  • Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.
  • Do not exceed recommended dosage.
  • As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a medical professional or a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Dissolve 1 tablet on tongue up to every 15 minutes for up to 12 doses per day.

Other Information:

SPL UNCLASSIFIED SECTION

Active ingredients are manufactured according to homeopathic principles.

Do not use if tamper evident seal beneath cap is broken or missing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Kollidon CL, Mannitol, Sodium stearyl fumarate 

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-500-26
Similasan®
Teething +
Tooth Support
BABY
135 Quick Dissolving
Tablets

PRINCIPAL DISPLAY PANEL NDC 59262-500-26 Similasan® Teething + Tooth Support BABY 135 Quick Dissolving TabletsPRINCIPAL DISPLAY PANEL NDC 59262-500-26 Similasan® Teething + Tooth Support BABY 135 Quick Dissolving Tablets

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
59262-500-262020-01-31C16284748780-19d75b9d0-a6e7-f424-e053-dadaa90a57ceBaby Teething Plus Tooth Support

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-500-26Baby Teething Plus Tooth Support135 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1352
59262-500-26Baby Teething Plus Tooth Support1 in 1 BOXTABLET, ORALLY DISINTEGRATING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-500BABY TEETHING PLUS TOOTH SUPPORT (OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, AND PODOPHYLLUM) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]2Legacy NDC, 2 package rows20151027_f546e13d-e535-49ba-9169-cfc4ee6a6775.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-500-26EA - Each59262-50074b57fcf-c903-45d8-a50e-5dc061a5bee212022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI2
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F72
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I2
PODOPHYLLUMACTIVE INGREDIENT2S713A4VP32
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z282
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I2
PODOPHYLLUMACTIVE MOIETY2S713A4VP32
MANNITOLINACTIVE INGREDIENT3OWL53L36A2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UI2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-50059262-500-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
PODOPHYLLUM2S713A4VP3ACTIB
MANNITOL3OWL53L36AIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT

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 2 · 82 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, ORALLY DISINTEGRATING / ORAL153 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UIGRANULE / ORAL77 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, CONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION/ DROPS / OPHTHALMIC4.6 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / OPHTHALMIC4.7 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / TOPICAL4 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION / OPHTHALMIC9 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / ORAL7093 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER / ORAL4352 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AWAFER / ORAL642 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, EXTENDED RELEASE / ORAL1086 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ALOZENGE / ORAL20546 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / ORAL3391 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / PARENTERAL200 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACONCENTRATE / INTRAVENOUS220 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET / SUBLINGUAL29 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED / ORAL2309 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UIPOWDER, FOR SUSPENSION / ORAL3.74 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UICAPSULE, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION / INTRAMUSCULAR71 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / SUBLINGUAL495 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / SUBCUTANEOUS675 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, COATED / ORAL1.18 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UICAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UIPELLET / ORAL43 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, COATED / ORAL177.7 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATROCHE / ORAL14594 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGUM, CHEWING / BUCCAL891 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION / SUBCUTANEOUS4.54 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, GEL FORMING / DROPS / OPHTHALMIC4 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FOR SUSPENSION / ORAL7621 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1568 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBCUTANEOUS99 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, CHEWABLE, EXTENDED RELEASE / ORAL616 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS180 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AGRANULE, FOR SUSPENSION / ORAL6000 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii candidate
65 equally ranked IID candidates
SODIUM STEARYL FUMARATESODIUM STEARYL FUMARATE7CV7WJK4UITABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
17 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR105 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR113 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ASOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC4.35 %w/wExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ACAPSULE, DELAYED RELEASE / ORAL2043 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS35 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS181 mgExact identifier — unii candidate
65 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
79fcc2ea-76bb-4b93-a844-ca3c83ef0402f546e13d-e535-49ba-9169-cfc4ee6a67752014-09-15WarningsExact identifier
spl id: 79fcc2ea-76bb-4b93-a844-ca3c83ef0402
spl set id: f546e13d-e535-49ba-9169-cfc4ee6a6775

Reported adverse events (FAERS/openFDA)#

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