FDA.reportPublic FDA data

BABY GUM RELIEF

Manufacturer
Similasan Corporation
Effective date
2018-08-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:25

Label at a glance#

ProductBABY GUM RELIEF
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CHAMOMILE, FERROSOFERRIC PHOSPHATE, PODOPHYLLUM
Label structure10 sections

Indications and uses

According to 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.

Storage and handling

Active ingredients are manufactured according to homeopathic principles. Do not use if tamper evident seal beneath cap is broken or missing. For more information, see http://www.similasanUSA.com/about-homeopathy

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Calcarea carbonica (Calcium) 12Xpain, difficult dentition
Calcarea fluorica (Calcium) 12Xsupports dental development
Calcarea phosphorica (Calcium) 12Xsupports dental development, pain, slow dentition
Chamomilla (Chamomile) 8Xswelling, irritability, restlessness, sleeplessness, red cheek/face
Ferrum phosphoricum 12Xpain
Podophyllum peltatum (May Apple) 12Xdrooling, chewing on things, irritability, fussiness or restlessness

UsesClaims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

  • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

Active ingredients are manufactured according to homeopathic principles.

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

For more information, see www.similasanUSA.com/about-homeopathy

Inactive ingredients

INACTIVE INGREDIENT SECTION

Crospovidone, Mannitol, Sodium stearyl fumarate

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
Similasan Corp., Highlands Ranch, CO 80129

PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-502-26

BELLADONNA
FREE

Similasan®

Baby Gum
Relief

QUICK DISSOLVING TABLETS

Formulated with
NATURAL ACTIVE INGREDIENTS

BABY

  • Chamomile for Irritability*
  • Triple Calcium Blend Supports
    Development of Healthy Teeth*
  • Benzocaine Free • Belladonna Free

HOMEOPATHIC
The Swiss Original

135 Quick Dissolving
Tablets (actual size)

PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box
PRINCIPAL DISPLAY PANEL - 135 Tablet Bottle Box

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
59262-502-262020-01-31C16284748780-19d75b9cf-dff1-f424-e053-dadaa90a57ceBABY GUM RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-502-26BABY GUM RELIEF1 in 1 BOXTABLET, ORALLY DISINTEGRATING12
59262-502-26BABY GUM RELIEF135 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-502BABY GUM RELIEF (CALCIUM FLUORIDE, CHAMOMILE, FERRUM PHOSPHORICUM, OYSTER SHELL CALCIUM CARBONATE, CRUDE, PODOPHYLLUM AND TRIBASIC CALCIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]2Legacy NDC, 2 package rows20180906_5d49e61d-7bd1-4211-bbad-80da9d7dfabf.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-50259262-502-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
CHAMOMILEFGL3685T2XACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
PODOPHYLLUM2S713A4VP3ACTIB
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
MANNITOL3OWL53L36AIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT

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
b0b8413d-2d5b-4e27-a213-5573dd1e3e0d5d49e61d-7bd1-4211-bbad-80da9d7dfabf2018-08-09WarningsExact identifier
spl id: b0b8413d-2d5b-4e27-a213-5573dd1e3e0d
spl set id: 5d49e61d-7bd1-4211-bbad-80da9d7dfabf

Reported adverse events (FAERS/openFDA)#

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