FDA.reportPublic FDA data

Comfort for Teething

Product NDC
64616-115
11-digit product format
646160115
Labeler code
64616
Product ID
64616-115_462f6324-888c-e31c-e063-6394a90ad915
Type
HUMAN OTC DRUG
Nonproprietary name
Comfort for Teething
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-07-05
Substance
MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED; CHAMOMILE; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE; RHEUM OFFICINALE ROOT
Active strength
6; 3; 6; 6; 6; 6 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Comfort for Teething
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED6 [hp_X]/.05mL
CHAMOMILE3 [hp_X]/.05mL
ARNICA MONTANA6 [hp_X]/.05mL
TRIBASIC CALCIUM PHOSPHATE6 [hp_X]/.05mL
WOOD CREOSOTE6 [hp_X]/.05mL
RHEUM OFFICINALE ROOT6 [hp_X]/.05mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W30T5D628QInternal UNII lookup
FGL3685T2XInternal UNII lookup
O80TY208ZWInternal UNII lookup
91D9GV0Z28Internal UNII lookup
3JYG22FD73Internal UNII lookup
A47JP5ZG9MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21b44c37-4fc8-14b4-e054-00144ff8d46cAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-115-01Comfort for Teething30 mL in 1 BOTTLE, DROPPERLIQUID308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-115COMFORT FOR TEETHING LIQUID [VITALITY WORKS, INC.]7Current NDC, Legacy NDC, 1 package rows20241212_21b44c37-4fc8-14b4-e054-00144ff8d46c.zip

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
Comfort for TeethingCOMFORT FOR TEETHINGVitality Works, Inc.21b44c37-4fc8-14b4-e054-00144ff8d46c2025-12-17WarningsExact identifier
ndc (product): 64616-115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-115-016461601150130 mL in 1 BOTTLE, DROPPER (64616-115-01) 30 ml2016-01-140000-00-00NoNoCurrent