FDA.reportPublic FDA data

Cold Sore Rescue

Product NDC
43846-0031
11-digit product format
438460031
Labeler code
43846
Product ID
43846-0031_c8fdf831-1f89-45a8-b490-b21d87580449
Type
HUMAN OTC DRUG
Nonproprietary name
BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA
Dosage form
GEL
Route
TOPICAL
Labeler
Peaceful Mountain, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-12-08
Substance
RANUNCULUS BULBOSUS WHOLE; SILICON DIOXIDE; SODIUM BORATE; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP
Active strength
30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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 Rescue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANUNCULUS BULBOSUS WHOLE30 [hp_X]/g
SILICON DIOXIDE30 [hp_X]/g
SODIUM BORATE30 [hp_X]/g
SODIUM CHLORIDE30 [hp_X]/g
SOLANUM DULCAMARA TOP30 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAEQ8NXJ0MB, ETJ7Z6XBU4, 91MBZ8H3QO, 451W47IQ8X, KPS1B1162N

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
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
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43846-0031-22024-06-13C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22024-01-30C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22020-04-24C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:
43846-0031-22020-01-31C16284748780-19d75b9d0-3181-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0031-1Cold Sore Rescue7 g in 1 TUBEGEL76
43846-0031-2Cold Sore Rescue1 in 1 CARTONGEL16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MBCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QOCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
BORATE IONACTIVE MOIETY44OAE30D22COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MBCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049PCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
OREGANOINACTIVE INGREDIENT0E5AT8T16UCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE63661499COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEGCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0031COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240615_a7fe6ec7-a758-43cf-b46f-c327e0632fb8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43846-0031-1438460031017 g in 1 TUBE7 gHistorical
43846-0031-2438460031021 TUBE in 1 CARTON (43846-0031-2) / 7 g in 1 TUBE (43846-0031-1) 1 tube2014-12-080000-00-00NoNoCurrent