FDA.reportPublic FDA data

Cold Sore Treatment

Product NDC
51393-5013
11-digit product format
513935013
Labeler code
51393
Product ID
51393-5013_bfe05bb1-b520-47bd-ad42-4ff41d15d817
Type
HUMAN OTC DRUG
Nonproprietary name
echinacea angustifolia whole, sodium chloride, thuja occidentalis leafy twig, and calendula officinalis flowering top
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-09-11
Substance
CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA WHOLE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
10; 10; 10; 10 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sore Treatment
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA ANGUSTIFOLIA WHOLE10 [hp_X]/100mL
SODIUM CHLORIDE10 [hp_X]/100mL
THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]/100mL
CALENDULA OFFICINALIS FLOWERING TOP10 [hp_X]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB06AV5US8Internal UNII lookup
451W47IQ8XInternal UNII lookup
1NT28V9397Internal UNII lookup
18E7415PXQInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a5d32dc-c0e7-404e-85f2-6c3a338560baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-5013-1Cold Sore Treatment Extra Strength1 in 1 CARTONSOLUTION/ DROPS11
51393-5013-1Cold Sore Treatment Extra Strength11 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS111
51393-5013-4Cold Sore Treatment Extra Strength4 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS41
51393-5013-4Cold Sore Treatment Extra Strength1 in 1 CARTONSOLUTION/ DROPS11

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
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact identifier
ndc (product): 51393-5013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51393-5013-1513935013011 BOTTLE, DISPENSING in 1 CARTON (51393-5013-1) / 11 mL in 1 BOTTLE, DISPENSING2025-09-11NoNoCurrent
51393-5013-4513935013041 BOTTLE, DISPENSING in 1 CARTON (51393-5013-4) / 4 mL in 1 BOTTLE, DISPENSING2025-09-11NoNoCurrent